Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

Study Overview
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Brief Summary
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The purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity

Detailed Description
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The primary aim is to compare 4 different connective tissue graft harvesting techniques in terms of morbidity and in terms of quality of the graft. The secondary aim is to evaluate the outcome of gingival recessions treated with grafts obtained from different harvesting approaches, in terms of mean root coverage, complete root coverage, keratinized tissue gain, clinical attachment level gain and gingival thickness

Official Title
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Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study

Conditions
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Gingival Recession, Palate; Wound

Intervention / Treatment
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* Procedure: DGG Harvesting approach
* Procedure: ET harvesting approach
* Procedure: TDT harvesting approach
* Procedure: MT harvesting approach
* Procedure: Root coverage procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or greater, Patients with no reported systemic diseases, Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy, Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15%, Clinical indication for periodontal plastic surgery utilizing CTG to treat either a single or a maximum of two recession defects (Miller class I, II) around natural teeth No history of previous palatal harvesting Exclusion Criteria: Pregnancy Systemic condition that generally precludes surgical therapy or that could influence the outcome of therapy (e.g. Diabetes with HbA1c > 7%, INR > 3 etc.) Non-compensated systemic disease Poor oral hygiene with full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) > 20% at baseline Inadequate endodontic treatment or tooth mobility at the site of surgery Radiographic evidence of bone loss

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 |
| --- | --- |
| Experimental: De-epithelialized gingival graft (DGG)<br>A harvesting approach where the a graft is obtained from the superficial palate and then extra-orally de-epithelialized in order to obtain a connective tissue graft (DGG harvesting approach) Then the DGG is used for treating gingival recessions (root coverage procedure) | Procedure: DGG Harvesting approach<br>* An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft<br>Procedure: Root coverage procedure<br>* A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft<br>|
| Experimental: Envelope technique (ET)<br>A harvesting approach where only one horizontal incision is performed on the palate (ET harvesting approach) for harvesting a connective tissue graft. Then the connective tissue graft is used for treating gingival recessions (root coverage procedure) | Procedure: ET harvesting approach<br>* A connective tissue graft is harvested from the palate after reflecting a primary palatal flap<br>Procedure: Root coverage procedure<br>* A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft<br>|
| Experimental: Trap door technique (TDT)<br>A harvesting approach where one horizontal and two vertical incisions are performed on the palate (TDT harvesting approach) for harvesting a connective tissue graft. Then the connective tissue graft is used for treating gingival recessions (root coverage procedure) | Procedure: TDT harvesting approach<br>* A connective tissue graft is harvested from the palate after reflecting a primary palatal flap<br>Procedure: Root coverage procedure<br>* A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft<br>|
| Experimental: Maxillary tuberosity (MT)<br>A harvesting approach that obtains an epithelialized gingival graft from the maxillary tuberosity (MT harvesting approach) which is then extra-orally de-epithelialized in order to obtain a connective tissue graft. Then the connective tissue graft is used for treating gingival recessions (root coverage procedure) | Procedure: MT harvesting approach<br>* An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft<br>Procedure: Root coverage procedure<br>* A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient morbidity (VAS) | Patient post-operative pain measured using a VAS scale | 14 days | 
| Mean root coverage (mRC) | mRC measured as a percentage | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level (CAL) gain | CAL gain measured in mm | 6 months | 
| Gingival thickness (GT) | CAL gain measured in mm | 6 months | 
| Patient willingness for retreatment | Patient willingness for retreatment (related to graft harvesting), if necessary, expressed as yes or no | 14 days | 
| Painkillers consumption | Painkiller consumption expressed in mg | 14 days | 
| Root coverage Esthetic Score (RES) | RES measured using numeric values from 0 to 10 | 6 months | 
| Keratinized tissue (KT) gain | KT gain measured in mm | 6 months |