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

NCT03661619 | Unknown

• 1 other identifier: K171206J
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Gingival recession; Root coverage; Periodontal plastic surgery; Subepithelial connective tissue graft

Outcome Measures

Primary Outcomes (1)

• Gingival recession

  The distance from CEJ to the gingival margin in the mid-buccal site of the treated tooth. Recession will be measured where there is the greatest distance between the marginal gingiva and the cemento-enamel junction (CEJ) in the vertical direction.

  12 months

Secondary Outcomes (6)

• Pocket depth

  12 months

• Keratinized tissue heigth

  12 months

• Aesthetic evaluation

  12 months

• Post operative morbidity assessment

  2 weeks

• Aesthetics and satisfaction assessment

  12 months

Study Arms (2)

Control Group

EXPERIMENTAL

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

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

Test Group

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: Palatal graft

Control Group

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

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

Also known as: Tuberosity graft

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females must be at least 18 years of age.
• Patients must be in good general health without any systemic diseases.
• Presence of buccal gingival recession (Miller's Class I and II) \>2 mm.
• Identifiable cemento-enamel junction.
• The tooth with a gingival recession is a vital tooth.
• Accessible tuberosity.
• Plaque Index and Gingival bleeding index less than 20%.
• Use an atraumatic dental brushing technique.
• Provide signed and dated informed consent form.
• Social health insurance.

You may not qualify if:

• The tooth with a gingival recession is a molar
• Prosthetic crown, restoration or tooth decay involving the CEJ
• Previous periodontal plastic surgery in the area
• Smokers up to 10 per day.
• Patient with untreated periodontal disease.
• Presence of clinical signs of active periodontal disease
• Known pregnancy in progress
• Contraindication to surgery
• Patient deprived of liberty or under legal protection measure.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Philippe BOUCHARD, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe BOUCHARD, PU-PH

CONTACT

+33 6 14 65 69 47; philippe.bouchard.perio@gmail.com

Sébastien MOREAUX, MD

CONTACT

+33 6 21 52 34 66; sn.moreaux@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: September 7, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share