Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

Not Applicable

Completed

• Conditions: Palate; Wound; Gingival Recession
• Interventions: Procedure: DGG Harvesting approach; Procedure: MT harvesting approach; Procedure: TDT harvesting approach; Procedure: ET harvesting approach; Procedure: Root coverage procedure

• Registration Number: NCT03584906
• Lead Sponsor: University of Milan

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 Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Study Start: 2018-08-16
• Primary Completion: 2020-05-28
• Status Verified: 2020-06
• Study Completion: 2020-06-15
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
De-epithelialized gingival graft (DGG)	DGG Harvesting approach	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)
Maxillary tuberosity (MT)	MT harvesting approach	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)
Trap door technique (TDT)	TDT harvesting approach	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)
De-epithelialized gingival graft (DGG)	Root coverage procedure	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)
Trap door technique (TDT)	Root coverage procedure	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)
Envelope technique (ET)	Root coverage procedure	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)
Maxillary tuberosity (MT)	Root coverage procedure	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)
Envelope technique (ET)	ET harvesting approach	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)

Primary Outcome Measures

Name	Time	Method
Patient morbidity (VAS)	14 days	Patient post-operative pain measured using a VAS scale
Mean root coverage (mRC)	6 months	mRC measured as a percentage

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Milan; 🇮🇹 Milan, Italy

Studio Odontoiatrico; 🇮🇹 Piacenza, Italy