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Tuberosity Versus Palatal Donor Site for Subepithelial Connective Tissue Graft in Root Coverage Therapy (TOPGRAFT)

NCT03661619 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-10-11

No results posted yet for this study

Summary

Gingival recessions are characterized by the apical migration of the marginal gingivae toward the cemento-enamel junction. Our team in France reported that 84,6% of the population exhibited gingival recession. Other epidemiologic data report that 25% of an american population exhibit recessions deeper than 3mm.

Recessions may be associated with thermic or mecanic related pains and increased wear of the roots. It may causes aesthetic prejudice on smiling. It may also complicate prosthetic reconstruction when the volume of tissue are insufficient. A study on a Brazilian population reported that recessions negatively impacted the quality of life in terms of esthetics and root sensitivity.

Many surgical procedures have been created to treat these recessions. Most of them include a gingival graft by mean of a sub-epithelial connective tissue graft. Usually it is harvested in the hard palate. However, the early healing of the palate may be associated with important pain and discomfort. Another harvesting site is the retromolar tuberosity. It seems to be of higher tissular quality and lower healing complications. However its limited volume prevent the harvesting of large graft.

Almost no studies have compared the clinical outcome between palatal and tuberosity graft. A retrospective study of our team reported higher rate of complet root coverage with tuberosity graft versus palatal graft (OR=3,78 IC95%). After this observational study, our work introduce a interventional comparison between the two harvesting sites.

Conditions

  • Gingival Recession

Interventions

PROCEDURE

Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure

Envelope technique + sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure

PROCEDURE

Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure

Envelope technique + sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Philippe BOUCHARD, PU-PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2020-10-31
Completion
2020-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661619 on ClinicalTrials.gov