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Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

Primary Purpose

Gingival Recession, Palate; Wound

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DGG Harvesting approach
ET harvesting approach
TDT harvesting approach
MT harvesting approach
Root coverage procedure
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Milan
  • Studio Odontoiatrico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

De-epithelialized gingival graft (DGG)

Envelope technique (ET)

Trap door technique (TDT)

Maxillary tuberosity (MT)

Arm 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)

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)

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)

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)

Outcomes

Primary Outcome Measures

Patient morbidity (VAS)
Patient post-operative pain measured using a VAS scale
Mean root coverage (mRC)
mRC measured as a percentage

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2018
Last Updated
June 29, 2020
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT03584906
Brief Title
Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.
Official Title
Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Palate; Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
De-epithelialized gingival graft (DGG)
Arm Type
Experimental
Arm 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)
Arm Title
Envelope technique (ET)
Arm Type
Experimental
Arm 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)
Arm Title
Trap door technique (TDT)
Arm Type
Experimental
Arm 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)
Arm Title
Maxillary tuberosity (MT)
Arm Type
Experimental
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
DGG Harvesting approach
Intervention Description
An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
ET harvesting approach
Intervention Description
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
Intervention Type
Procedure
Intervention Name(s)
TDT harvesting approach
Intervention Description
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
Intervention Type
Procedure
Intervention Name(s)
MT harvesting approach
Intervention Description
An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Root coverage procedure
Intervention Description
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
Primary Outcome Measure Information:
Title
Patient morbidity (VAS)
Description
Patient post-operative pain measured using a VAS scale
Time Frame
14 days
Title
Mean root coverage (mRC)
Description
mRC measured as a percentage
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical attachment level (CAL) gain
Description
CAL gain measured in mm
Time Frame
6 months
Title
Gingival thickness (GT)
Description
CAL gain measured in mm
Time Frame
6 months
Title
Patient willingness for retreatment
Description
Patient willingness for retreatment (related to graft harvesting), if necessary, expressed as "yes" or "no"
Time Frame
14 days
Title
Painkillers consumption
Description
Painkiller consumption expressed in mg
Time Frame
14 days
Title
Root coverage Esthetic Score (RES)
Description
RES measured using numeric values from 0 to 10
Time Frame
6 months
Title
Keratinized tissue (KT) gain
Description
KT gain measured in mm
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulio Rasperini, DDS
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Milan
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Studio Odontoiatrico
City
Piacenza
ZIP/Postal Code
29121
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20590963
Citation
Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
Results Reference
background
PubMed Identifier
29761502
Citation
Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravida A, Wang HL. Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. J Periodontol. 2018 Sep;89(9):1075-1090. doi: 10.1002/JPER.18-0066. Epub 2018 Aug 13.
Results Reference
background
PubMed Identifier
29713890
Citation
Tavelli L, Ravida A, Saleh MHA, Maska B, Del Amo FS, Rasperini G, Wang HL. Pain perception following epithelialized gingival graft harvesting: a randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):459-468. doi: 10.1007/s00784-018-2455-5. Epub 2018 Apr 30.
Results Reference
background
PubMed Identifier
18315424
Citation
Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
Results Reference
background
PubMed Identifier
11203571
Citation
Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305.
Results Reference
background

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Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

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