Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milan
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Patient morbidity (VAS)
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
De-epithelialized gingival graft (DGG)
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)
Intervention: DGG Harvesting approach (Procedure)
De-epithelialized gingival graft (DGG)
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)
Intervention: Root coverage procedure (Procedure)
Envelope technique (ET)
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)
Intervention: ET harvesting approach (Procedure)
Envelope technique (ET)
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)
Intervention: Root coverage procedure (Procedure)
Trap door technique (TDT)
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)
Intervention: TDT harvesting approach (Procedure)
Trap door technique (TDT)
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)
Intervention: Root coverage procedure (Procedure)
Maxillary tuberosity (MT)
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)
Intervention: MT harvesting approach (Procedure)
Maxillary tuberosity (MT)
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)
Intervention: Root coverage procedure (Procedure)
Outcomes
Primary Outcomes
Patient morbidity (VAS)
Time Frame: 14 days
Patient post-operative pain measured using a VAS scale
Mean root coverage (mRC)
Time Frame: 6 months
mRC measured as a percentage
Secondary Outcomes
- Keratinized tissue (KT) gain(6 months)
- Painkillers consumption(14 days)
- Root coverage Esthetic Score (RES)(6 months)
- Clinical attachment level (CAL) gain(6 months)
- Gingival thickness (GT)(6 months)
- Patient willingness for retreatment(14 days)
Investigators
Giulio Rasperini
Professor of Periodontology
University of Milan