Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Around Implants

Study Overview
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Brief Summary
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The purpose of this study is to assess the influence of two different flap designs (envelope Coronally Advanced Flap (eCAF) and Modified Tunnel Technique (MTT)) with the addition of a connective tissue graft (CTG) in treating soft tissue dehiscences at implant sites

Detailed Description
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The primary aim is to compare the test and control groups in terms of: mean mid-facial recession coverage (mRC) measured as a percentage the keratinized tissue (KT) gain measured in mm the keratinized tissue thickness (KTT) gain measured in mm. The secondary aims are to compare the two groups in terms of: Esthetic score, using numeric values from 0 to 10 patient-reported esthetics, using numeric values from 1 to 5 patient-reported post-operative pain, based on Visual Analog Scale (VAS) scale, measured as numbers from 0 to 10.

Official Title
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Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Coverage Around Implants: A Randomized Clinical Trial

Conditions
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Dental Implants

Intervention / Treatment
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* Procedure: Mucogingival surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Periodontally and systemically healthy Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth) Correct implant 3-dimensional position or buccal position ≤ 1 mm Buccal soft tissue dehiscence ≤ 4 mm Only osseointegrated implants The patient must be able to perform good oral hygiene Exclusion Criteria: Contraindications for periodontal surgery Patients pregnant or attempting to get pregnant Malpositioned implant Soft tissue dehiscence (STD) > 4 mm Multiple adjacent implants with STD Existing of peri-implantitis Severe bone loss (≥4mm) Moderate-severe interproximal bone loss (implant fixture level to the alveolar bone > 3 mm) Moderate-severe papilla height loss (Nordland and Tarnow implant papillae index >1) Previous mucogingival surgery around the implant within the past six months or implant placement at the surgical site less than six months prior Smoking more than 10 cigarettes a day

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: envelope Coronally Advanced Flap (eCAF)<br>A mucogingival surgery where an envelope flap is coronally advanced and sutured to cover the mucosal recession | Procedure: Mucogingival surgery<br>* The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa<br>|
| Experimental: Modified Tunnel Technique (MTT)<br>A mucogingival surgery where the gingiva is released without reflecting a flap (as described for tunnel techniques) and then coronally advanced and sutured to cover the mucosal recession | Procedure: Mucogingival surgery<br>* The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean mid-facial recession coverage (mRC) | mRC measured as a percentage | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetic score | Esthetic score measured using numeric values from 0 to 10 | 6 months and 1 year | 
| Patient-reported esthetics | Patient-reported esthetics measured using numeric values from 1 to 5 | 6 months and 1 year | 
| Patient-reported post-operative pain | Patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10. | 2 weeks | 
| Keratinized tissue (KT) gain | KT gain measured in mm | 6 months and 1 year | 
| Keratinized tissue thickness (KTT) | KTT gain measured in mm | 6 months and 1 year |