Comparative evaluation of effectiveness of soft tissue augmentation around implants with tissue-engineered scaffold versus autogenous sub-epithelial connective tissue graft – a randomized controlled study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
Dental implants are a predictable option for restoring edentulous or partially edentulous patients, but tooth-borne pathology often results in horizontal or vertical bone defects and inadequate soft tissue at implant sites. Mucogingival surgery is frequently used to improve the quality and quantity of peri-implant soft tissue, supporting peri implant health, esthetics, and patient comfort during oral hygiene.
Soft tissue augmentation serves two main objectives
-
Increasing the width of attached keratinized mucosa to facilitate hygiene
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Increasing soft tissue volume to create a favorable, convex peri-implant mucosal contour.
These procedures are associated with improved short and long term biological, functional, and esthetic outcomes. Augmentation may also help maintain marginal bone levels by improving the soft tissue seal around implants.
Autogenous subepithelial connective tissue grafts remain the gold standard for augmenting soft tissue volume, but they present disadvantages such as anatomical limitations in graft size and donor site morbidity, including postoperative pain and numbness. To reduce these issues, alternative soft tissue substitutes have been developed. One such emerging option is a tissue-engineered scaffold incorporating fibroblast growth factor (FGF2).
This study aims to evaluate the benefits of soft tissue augmentation at implant sites and to compare the effectiveness of an FGF2 enhanced tissue engineered scaffold with that of autogenous grafts for peri implant soft tissue augmentation.
Primary outcome
To determine the efficacy of soft tissue augmentation in improving and or maintaining peri implant health (thickness of peri implant soft tissue and width of attached gingiva on baseline T0, after 1 month T1, and after 3 months T2) and esthetics (Pink Esthetic Score at baseline T0 and after 3 months T2).
Secondary outcomes
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To evaluate and compare the effects of tissue engineered scaffold with FGF2 on peri implant health (thickness of peri implant soft tissue and width of attached gingiva on baseline T0, after 1 month T1, and after 3 months T2) and esthetics (Pink Esthetic Score at baseline T0 and after 3 months T2) with those of conventional subepithelial connective tissue graft
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To determine the patient perceived satisfaction and cost effectiveness of tissue engineering scaffold with FGF2 in comparison to sub epithelial connective tissue graft (questionnaire based).
Control group
Dental implant placement without any soft tissue augmentation procedure
Test group 1
Dental implant placement with soft tissue augmentation using autogenous subepithelial connective tissue graft.
Test group 2
Dental implant placement with soft tissue augmentation using tissue engineered scaffold incorporated with FGF2.
The patients will then be asked to report for regular follow ups to monitor proper healing of the surgical sites(s) and for recording of clinical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults between 18-60 years of age.
- •Patients planned for dental implant placement.
- •Full mouth plaque scores (FMPS) and full mouth bleeding scores (FMBS) less than 20 percent after non-surgical periodontal therapy.
- •Non-smokers or former smokers (not smoked within 6 months of study initiation).
- •Ability to comply with the study-related procedures, such as exercising good oral hygiene and attending all follow-up examinations.
- •Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form.
排除标准
- •Patients with clinically significant or unstable systemic diseases or compromised healing potential (i.e. connective tissue disorders or bone metabolic diseases).
- •Patients with history of antibiotic, non-steroidal anti-inflammatory medication or on drug affecting periodontal status for greater or equal to two weeks prior to enrolment in the study.
- •Pregnant or lactating women.
- •History of periodontal surgery within the last one year of enrolment.
研究者
Dr Ashutosh Srivastava
Faculty of Dental Sciences, King Georges Medical University