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Completed

NCT Number: NCT03584906

Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Milan, Milan, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DGG Harvesting approach

Procedure

An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft

ET harvesting approach

Procedure

A connective tissue graft is harvested from the palate after reflecting a primary palatal flap

TDT harvesting approach

Procedure

A connective tissue graft is harvested from the palate after reflecting a primary palatal flap

MT harvesting approach

Procedure

An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft

Root coverage procedure

Procedure

A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2018
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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