Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

June 29, 2020 updated by: Giulio Rasperini, University of Milan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • University of Milan
      • Piacenza, Italy, 29121
        • Studio Odontoiatrico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Procedure: DGG Harvesting approach
An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft
Procedure: Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
Experimental: 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)
Procedure: Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
Procedure: ET harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
Experimental: 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)
Procedure: Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
Procedure: TDT harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
Experimental: 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)
Procedure: Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
Procedure: MT harvesting approach
An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Giulio Rasperini, DDS, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2018

Primary Completion (Actual)

May 28, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Palatal Harvesting and CTG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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