Evaluation of Linear and Volumetric Soft Tissue Changes Following the Application of Topical Oxygen Therapy Around Customized Healing Collars: Case Series
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Soft tissue dimensional changes
研究概览
简要总结
The preservation and enhancement of peri-implant soft tissues are essential for the long-term success and esthetic integration of dental implants. Customized healing abutments have been introduced to support individualized soft tissue shaping; however, optimizing soft tissue healing around implants remains a clinical challenge. Oxygen plays a critical role in wound healing by promoting angiogenesis, fibroblast proliferation, and collagen synthesis. Topical oxygen therapy has shown promise in accelerating tissue regeneration, yet its application in oral implantology, particularly in conjunction with customized healing abutments, has not been adequately studied. This study aims to provide clinical evidence regarding the effectiveness of topical oxygen therapy in improving linear and volumetric soft tissue changes around dental implants. The findings may guide clinicians in refining soft tissue management protocols and contribute to establishing evidence-based practices in implant dentistry.
详细描述
Interventions
Preoperative Measures Prior to the second-stage surgical procedure, all participants will undergo a standardized preoperative assessment to ensure their suitability for implant exposure and subsequent healing abutment placement.
The following components will be systematically conducted:
- Medical and Dental History Evaluation A comprehensive evaluation of each patient's medical and dental history will be performed to identify any systemic conditions or pharmacological agents that may compromise wound healing or elevate the risk of postoperative complications.
- Clinical and Radiographic Assessment A detailed clinical examination will be undertaken to evaluate the thickness of the soft tissue, the width of keratinized mucosa, and the condition of the mucosa overlying the implant site. Radiographic assessment using periapical radiographs or cone-beam computed tomography (CBCT), where indicated, will be conducted to confirm successful osseointegration of the dental implant and to exclude any evidence of peri-implant pathology.
- Oral Hygiene Evaluation and Instruction Oral hygiene status will be assessed using the Plaque Index. Patients will receive personalized oral hygiene instructions to ensure optimal plaque control before the surgical intervention. In cases where oral hygiene is deemed suboptimal, professional mechanical plaque removal (PMPR) will be provided, followed by re-evaluation prior to proceeding with the second-stage surgery.
Surgical Protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 21 years and above.
- •Indicated for customized healing collar placement after second-stage surgery.
- •Good general health.
- •Able and willing to provide written informed consent.
- •Committed to follow-up visits.
排除标准
- •Individuals below 21 years old.
- •Systemic diseases affecting healing.
- •Smokers/tobacco users.
- •Pregnant/lactating women.
- •Medications affecting soft tissue healing.
- •Chemotherapy/radiotherapy patients.
研究组 & 干预措施
Topical Oxygen therapy
Participants will undergo a standardized preoperative assessment prior to second-stage implant surgery, including medical and dental history review, clinical and radiographic evaluation to confirm implant osseointegration, and oral hygiene assessment with reinforcement as needed.
During the second-stage procedure, local anesthesia will be administered, followed by a crestal incision to access the implant site. After removal of the cover screw, a customized PEEK healing abutment will be placed.
Immediately after abutment placement, Blue®M oral gel (Blue®M Europe BV, The Netherlands) will be applied around the healing collar and gently massaged into the peri-implant mucosa. Participants will continue topical application twice daily for 7 days.
Standard postoperative care will be provided. Clinical evaluations will be performed at baseline, 7 days, and 21 days to assess soft tissue changes, patient-reported outcomes, and clinical photographs.
干预措施: topical oxygen therapy (Procedure)
结局指标
主要结局
Soft tissue dimensional changes
时间窗: baseline: preoperative and after 3 months and after 6 months
Horizontal Tissue Linear Alterations were measured in millimeters by superimposing baseline and follow-up 3D digital models and calculating the Mean Buccal Change (MBC) and Mean Total Change (MTC) using software such as ImageJ, Geomagic, or MeshLab at standardized buccal reference points. Vertical Linear Tissue Alterations were quantified in millimeters by evaluating changes in Mesial Papillae Height Variation (mPHv), Distal Papillae Height Variation (dPHv), Papillae Height Variation (PHv), and Midfacial Height Variation (MFHv) through calibrated digital photography or intraoral scanning relative to fixed anatomical landmarks.
Pink Esthetic Score (PES)
时间窗: baseline: preoperative and after 3 months and after 6 months
determined by scoring seven soft tissue parameters (papillae, mucosal contour, level, color, and texture) from 0 to 2, based on clinical photographs compared with adjacent teeth, yielding a total score ranging from 0 to 14.
次要结局
- Postoperative Pain(baseline: at day 1 , day 3 , day 10)
- Wound Healing(Baseline : day 1 , day 3 ,day 10)
研究者
Mulhem Ahmad
Principal Investigator Mulhem Ahmad
Cairo University