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Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

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ClinicalTrials.gov Identifier: NCT03584906
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Giulio Rasperini, 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

Condition or disease Intervention/treatment Phase
Gingival Recession Palate; Wound Procedure: DGG Harvesting approach Procedure: ET harvesting approach Procedure: TDT harvesting approach Procedure: MT harvesting approach Procedure: Root coverage procedure Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : April 28, 2019
Estimated Study Completion Date : April 28, 2019

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: ET harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap

Procedure: Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft

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: TDT harvesting approach
A connective tissue graft is harvested from the palate after reflecting a primary palatal flap

Procedure: Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft

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: 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

Procedure: Root coverage procedure
A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft




Primary Outcome Measures :
  1. Patient morbidity (VAS) [ Time Frame: 14 days ]
    Patient post-operative pain measured using a VAS scale

  2. Mean root coverage (mRC) [ Time Frame: 6 months ]
    mRC measured as a percentage


Secondary Outcome Measures :
  1. Clinical attachment level (CAL) gain [ Time Frame: 6 months ]
    CAL gain measured in mm

  2. Gingival thickness (GT) [ Time Frame: 6 months ]
    CAL gain measured in mm

  3. Patient willingness for retreatment [ Time Frame: 14 days ]
    Patient willingness for retreatment (related to graft harvesting), if necessary, expressed as "yes" or "no"

  4. Painkillers consumption [ Time Frame: 14 days ]
    Painkiller consumption expressed in mg

  5. Root coverage Esthetic Score (RES) [ Time Frame: 6 months ]
    RES measured using numeric values from 0 to 10

  6. Keratinized tissue (KT) gain [ Time Frame: 6 months ]
    KT gain measured in mm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584906


Locations
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Italy
University of Milan
Milan, Italy, 20122
Studio Odontoiatrico
Piacenza, Italy, 29121
Sponsors and Collaborators
University of Milan
Investigators
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Principal Investigator: Giulio Rasperini, DDS University of Milan

Publications:
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Responsible Party: Giulio Rasperini, Professor of Periodontology, University of Milan
ClinicalTrials.gov Identifier: NCT03584906     History of Changes
Other Study ID Numbers: Palatal Harvesting and CTG
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy