Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs
研究概览
简要总结
This study has been initiated to evaluate the question, "What is the best way to protect the palate after a gum graft is removed?" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.
详细描述
This study aims to determine if there is a difference in subject-reported outcome measures (PROMs) when different palatal post-operative protection techniques are used during healing after an autogenous soft-tissue graft is harvested from the palate for periodontal and peri-implant plastic surgery. The secondary objective is to evaluate if there is a difference in the healing of the palatal tissue via photographic and 3D linear and volumetric changes analysis after using the different protective techniques. Furthermore, the study will evaluate the time needed for fabrication and intraoral adjustment of each protective barrier and professional preference among the techniques utilized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Healthy or Mild controlled systemic diseases with no functional limitations (ASA I or ASA II)
- •Sites with 1 to 3 teeth or implants requiring soft-tissue grafting
- •Minimum palatal thickness of 2 mm
- •Willing to participate and sign an informed consent
排除标准
- •Patients with systemic conditions that could impair wound healing (i.e. diabetes, immunosuppressive, chemotherapy, etc.)
- •Pregnant patients
- •Patients with bleeding disorders or taking anticoagulants
- •Patients with a history of palatal graft harvesting
研究组 & 干预措施
Vacuum-formed retainer (VFR): plastic device
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model of the jaw.. A resin model will be 3D printed generating the physical model. A palatal stent will be made out of thermoforming plastic in the model using a vacuum, The stent will cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. On the day of the surgery, at the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made plastic palatal stent (VFR) will be placed in position and stabilized by mechanical retention using the palate and maxillary teeth, bilaterally. The subjects will be instructed to wear the stent uninterruptedly in the first 3 days and per their preference on the 4th day and after.
干预措施: Visual Analog scale (VAS) questionnaire (Other)
Vacuum-formed retainer (VFR): plastic device
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model of the jaw.. A resin model will be 3D printed generating the physical model. A palatal stent will be made out of thermoforming plastic in the model using a vacuum, The stent will cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. On the day of the surgery, at the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made plastic palatal stent (VFR) will be placed in position and stabilized by mechanical retention using the palate and maxillary teeth, bilaterally. The subjects will be instructed to wear the stent uninterruptedly in the first 3 days and per their preference on the 4th day and after.
干预措施: Vacuum-formed retainer (VFR) technique (Other)
Vacuum-formed retainer (VFR): plastic device
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model of the jaw.. A resin model will be 3D printed generating the physical model. A palatal stent will be made out of thermoforming plastic in the model using a vacuum, The stent will cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. On the day of the surgery, at the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made plastic palatal stent (VFR) will be placed in position and stabilized by mechanical retention using the palate and maxillary teeth, bilaterally. The subjects will be instructed to wear the stent uninterruptedly in the first 3 days and per their preference on the 4th day and after.
干预措施: Photographs of the patient's palate (Other)
Vacuum-formed retainer (VFR): plastic device
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model of the jaw.. A resin model will be 3D printed generating the physical model. A palatal stent will be made out of thermoforming plastic in the model using a vacuum, The stent will cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. On the day of the surgery, at the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made plastic palatal stent (VFR) will be placed in position and stabilized by mechanical retention using the palate and maxillary teeth, bilaterally. The subjects will be instructed to wear the stent uninterruptedly in the first 3 days and per their preference on the 4th day and after.
干预措施: Measuring graft dimensions (Other)
3-D printed acrylic resin stent (3DS): digitally designed
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model file of the patient's jaws. A palatal stent will be digitally designed. The stent will cover the palatal area to the maximum extent, respecting the limit between the hard and soft palate to avoid any discomfort or gag reflex by the subjects. At the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.
干预措施: Visual Analog scale (VAS) questionnaire (Other)
3-D printed acrylic resin stent (3DS): digitally designed
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model file of the patient's jaws. A palatal stent will be digitally designed. The stent will cover the palatal area to the maximum extent, respecting the limit between the hard and soft palate to avoid any discomfort or gag reflex by the subjects. At the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.
干预措施: 3-D printed acrylic resin stent (3DS) technique (Other)
3-D printed acrylic resin stent (3DS): digitally designed
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model file of the patient's jaws. A palatal stent will be digitally designed. The stent will cover the palatal area to the maximum extent, respecting the limit between the hard and soft palate to avoid any discomfort or gag reflex by the subjects. At the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.
干预措施: Photographs of the patient's palate (Other)
3-D printed acrylic resin stent (3DS): digitally designed
Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model file of the patient's jaws. A palatal stent will be digitally designed. The stent will cover the palatal area to the maximum extent, respecting the limit between the hard and soft palate to avoid any discomfort or gag reflex by the subjects. At the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.
干预措施: Measuring graft dimensions (Other)
Flowable resin composite stent (FRC): mechanical barrier
After the placement of the graft and the suture of the recipient site, a collagen sponge will be positioned in the palatal wound. Then, a layer of cyanoacrylate (PeriAcryl 90HV, GluStitch) will be placed above the sponge using a microbrush. Non-resorbable sutures will be placed covering the palatal dressing, with the suture knots facing the buccal surfaces of the maxillary posterior teeth. Finally, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity. Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model for secondary analysis.
干预措施: Visual Analog scale (VAS) questionnaire (Other)
Flowable resin composite stent (FRC): mechanical barrier
After the placement of the graft and the suture of the recipient site, a collagen sponge will be positioned in the palatal wound. Then, a layer of cyanoacrylate (PeriAcryl 90HV, GluStitch) will be placed above the sponge using a microbrush. Non-resorbable sutures will be placed covering the palatal dressing, with the suture knots facing the buccal surfaces of the maxillary posterior teeth. Finally, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity. Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model for secondary analysis.
干预措施: Flowable resin composite stent (FRC) technique (Other)
Flowable resin composite stent (FRC): mechanical barrier
After the placement of the graft and the suture of the recipient site, a collagen sponge will be positioned in the palatal wound. Then, a layer of cyanoacrylate (PeriAcryl 90HV, GluStitch) will be placed above the sponge using a microbrush. Non-resorbable sutures will be placed covering the palatal dressing, with the suture knots facing the buccal surfaces of the maxillary posterior teeth. Finally, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity. Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model for secondary analysis.
干预措施: Photographs of the patient's palate (Other)
Flowable resin composite stent (FRC): mechanical barrier
After the placement of the graft and the suture of the recipient site, a collagen sponge will be positioned in the palatal wound. Then, a layer of cyanoacrylate (PeriAcryl 90HV, GluStitch) will be placed above the sponge using a microbrush. Non-resorbable sutures will be placed covering the palatal dressing, with the suture knots facing the buccal surfaces of the maxillary posterior teeth. Finally, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity. Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model for secondary analysis.
干预措施: Measuring graft dimensions (Other)
Chairside Polymer Stent:CPS: mechanical barrier
During the preoperative appoint, both dental arches scanned using an intraoral optical scanner scanner (TRIOS, 3Shape) to generate the digital model in .STL file of the patient's jaws. In this group, the .STL files of the digital models of patient's jaws are not necessary for the fabrication of the stent but will be stored for future analysis of secondary outcomes of the research that includes the healing of the palatal wound via volumetric and linear changes analysis. Before the graft has been harvested, 4 cubes of Zn-containing granules are placed into a warm water bath and manipulated into a 2mm disk and placed in the patient's mouth to be formed to fit the patient. After the graft has been harvested, the stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.
干预措施: Visual Analog scale (VAS) questionnaire (Other)
Chairside Polymer Stent:CPS: mechanical barrier
During the preoperative appoint, both dental arches scanned using an intraoral optical scanner scanner (TRIOS, 3Shape) to generate the digital model in .STL file of the patient's jaws. In this group, the .STL files of the digital models of patient's jaws are not necessary for the fabrication of the stent but will be stored for future analysis of secondary outcomes of the research that includes the healing of the palatal wound via volumetric and linear changes analysis. Before the graft has been harvested, 4 cubes of Zn-containing granules are placed into a warm water bath and manipulated into a 2mm disk and placed in the patient's mouth to be formed to fit the patient. After the graft has been harvested, the stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.
干预措施: Photographs of the patient's palate (Other)
Chairside Polymer Stent:CPS: mechanical barrier
During the preoperative appoint, both dental arches scanned using an intraoral optical scanner scanner (TRIOS, 3Shape) to generate the digital model in .STL file of the patient's jaws. In this group, the .STL files of the digital models of patient's jaws are not necessary for the fabrication of the stent but will be stored for future analysis of secondary outcomes of the research that includes the healing of the palatal wound via volumetric and linear changes analysis. Before the graft has been harvested, 4 cubes of Zn-containing granules are placed into a warm water bath and manipulated into a 2mm disk and placed in the patient's mouth to be formed to fit the patient. After the graft has been harvested, the stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.
干预措施: Measuring graft dimensions (Other)
Chairside Polymer Stent:CPS: mechanical barrier
During the preoperative appoint, both dental arches scanned using an intraoral optical scanner scanner (TRIOS, 3Shape) to generate the digital model in .STL file of the patient's jaws. In this group, the .STL files of the digital models of patient's jaws are not necessary for the fabrication of the stent but will be stored for future analysis of secondary outcomes of the research that includes the healing of the palatal wound via volumetric and linear changes analysis. Before the graft has been harvested, 4 cubes of Zn-containing granules are placed into a warm water bath and manipulated into a 2mm disk and placed in the patient's mouth to be formed to fit the patient. After the graft has been harvested, the stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.
干预措施: Chairside Polymer Stent (Other)
结局指标
主要结局
Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs
时间窗: Up to 2 weeks post-operatively
Evaluate postoperative pain level by documenting the number of pain pills taken during the initial two weeks of the healing process.
Evaluate swelling and bleeding perception after autogenous gingival graft comparing 3 different palatal dressing designs
时间窗: 2 weeks, 1 month and 3 months post-operative
Using a Visual Analog scale (VAS) questionnaire indicating the subject's perception of swelling and bleeding following the graft. The VAS is a type of self-report tool where subjects mark a point on a continuous line to indicate the intensity of a subjective experience between two extreme anchor points (e.g., "no pain" at one end and "worst possible pain" at the other), allowing for a more nuanced response compared to a standard Likert scale. Essentially, it measures the degree of a symptom along a visual continuum.
Evaluate the willingness to retreat by the subjects after autogenous gingival graft comparing 3 different palatal dressing designs
时间窗: 2 weeks, 1 month and 3 months post-operative
Using a Visual Analog scale (VAS) questionnaire indicating the subject's willingness to retreat following the graft. The VAS is a type of self-report tool where subjects mark a point on a continuous line to indicate the intensity of a subjective experience between two extreme anchor points (e.g., "no pain" at one end and "worst possible pain" at the other), allowing for a more nuanced response compared to a standard Likert scale. Essentially, it measures the degree of a symptom along a visual continuum.
次要结局
未报告次要终点
