Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

University of Milan

Status: Completed

Conditions: Palate; Wound; Gingival Recession

Treatments: Procedure: TDT harvesting approach; Procedure: Root coverage procedure; Procedure: DGG Harvesting approach; Procedure: MT harvesting approach; Procedure: ET harvesting approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03584906

Palatal Harvesting and CTG

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

De-epithelialized gingival graft (DGG)

Experimental group

Description:

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)

Treatment:

Procedure: Root coverage procedure

Procedure: DGG Harvesting approach

Envelope technique (ET)

Experimental group

Description:

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)

Treatment:

Procedure: Root coverage procedure

Procedure: ET harvesting approach

Trap door technique (TDT)

Experimental group

Description:

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)

Treatment:

Procedure: Root coverage procedure

Procedure: TDT harvesting approach

Maxillary tuberosity (MT)

Experimental group

Description:

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)

Treatment:

Procedure: Root coverage procedure

Procedure: MT harvesting approach