Peri-implant Tissue Stability Following Tissue Augmentation Harvested From Deep Palate or Tuberosity

Study Overview
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Brief Summary
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This study will compare peri implant tissue stability following connective tissue graft harvested fromLateral Palate or the Tuberosity Area. As far as we know, it remains controversial whether peri-implant soft tissue stability could be achieved after soft tissue augmentation with the connective tissue graft from the tuberosity or the lateral palate. Soft tissue stability evaluated by intra oral scanner will be described as primary outcome.

Detailed Description
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Ridge resorption is a common finding after tooth extraction. Recently, there is an increasing concern about this issue during implant-supported reconstruction in the esthetic zone. Although the previous studies supports the guided bone regeneration procedures for reconstruction of contour deficiencies, the replacement of the mineralized materials with the bone has been questioned. Therefore, recently, using connective tissue grafts instead of allogenic or xenogenic materials has been addressed. The palate is routinely used as the donor site for harvesting the connective tissue graft. The graft can be harvested by de-epithelialized method or it can be harvested conventionally from deep palate during flap elevation. Another choice for harvesting the connective tissue graft is the tuberosity area, which can be used when you need small to moderate amount of soft tissue (around 1-2 implants). The connective tissues harvested from these sites have quite different characteristics, which might influence on the fate of the treatment in terms of the stability. therefore, we decided to compare the stability of the grafts harvested from the deep palate or tuberosity.

Official Title
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Comparison of Peri-implant Tissue Stability Following Soft Tissue Augmentation Harvested From the Deep Palate or the Tuberosity Area: A Randomized Controlled Clinical Trial

Conditions
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Alveolar Ridge Augmentation, Tissue Transplantation, Tissue Donors

Intervention / Treatment
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* Procedure: connective tissue graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 18 years old. systemically and periodontally healthy patients. need of single implant placement between two maxillary teeth. need of tissue augmentation due to concavity or soft tissue thickness less than 2 millimetres . more than 3 month after extraction. full mouth plaque index lesser than 20%. sufficient mesiodistal and buccolingual space. At least 10 millimetres mesiodistal dimension in tuberosity. sufficient implant primary stability. at least 6 mm crestal ridge width. Exclusion Criteria: History of periodontitis and radiotherapy. Need of horizontal ridge augmentation. Previous soft tissue augmentation. Heavy smoker( more than 10 cigarette per day) Local or systemic conditions that would interfere with routine periodontal therapy.

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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Accepts Healthy Volunteers

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: CTG from deep palate<br>The connective tissue graft harvested from the deep palate during flap elevation for implant placement | Procedure: connective tissue graft<br>* Connective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area.<br>|
| Experimental: CTG from tuberosity<br>The connective tissue graft harvested from the tuberosity | Procedure: connective tissue graft<br>* Connective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| soft tissue volume change 0-3 | changes of soft tissue volume from baseline (immediately before surgery) to 3 months by intra oral scanner | from baseline (immediately before surgery) to 3 months | 
| soft tissue volume change 0-6 | changes of soft tissue volume from baseline (immediately before surgery) to 6 months by intra oral scanner | from baseline (immediately before surgery) to 6 months | 
| soft tissue volume change 3-6 | changes of soft tissue volume from 3 months to 6 months by intra oral scanner | from 3 months to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | immediately after surgery | 
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | day 1 | 
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | day 2 | 
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | day 3 | 
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | day 4 | 
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | day 5 | 
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | day 6 | 
| The level of the pain by questionnaire through visual analogue scale | evaluation of the level of the pain by questionnaire through visual analogue scale method | day 7 | 
| Palliative 0-7 | the number of palliatives the patient used during the first week after surgery | immediately after surgery to 7 days later | 
| Pink aesthetic score | evaluation of the aesthetic score by photography | 3 months after surgery | 
| Pink aesthetic score | evaluation of the aesthetic score by photography | 6 months after surgery |