Connective Tissue Grafting for Single Tooth Recession & the Impact of the Thickness of the Palatal Harvest Tissue

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Columbia University

Status

Completed

Conditions

Gingival Recession

Treatments

Procedure: connective tissue graft

Study type

Interventional

Funder types

Other

Identifiers

NCT03032094
AAAN2667

Details and patient eligibility

About

The purpose of this study is to test if the thickness of the graft taken from the roof of the mouth, has a significant effect on the amount of attached tissue and the amount of root coverage that are attained when treating a single tooth with gingival recession.

Full description

The goal of the study is to determine if the thickness of a tissue graft taken from the roof of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the root coverage, the health of the resulting tissue, as well as postoperative pain as reported by the patient. Connective tissue grafts will be harvested in different thicknesses, and results of the procedures will be compared. Qualified subjects will undergo a root coverage procedure, after random assignment to one of the groups. Regular recall visits to monitor healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. Subjects will be asked to fill out patient response forms regarding pain and other symptoms at these visits. Photographs will be taken.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age>18 years old
  • Absence of active periodontal disease
  • Single tooth (premolars and anterior teeth) with Miller class I or II gingival recession >= 2mm
  • Detectable Cemento-Enamel Junction (CEJ) -

Exclusion criteria

  • Smokers (>10 cigarettes/ per day)
  • Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c >7%)
  • Active infectious diseases (hepatitis, tuberculosis, HIV, etc.)
  • Medication known to cause gingival enlargement
  • Patients taking anticoagulants with an international normalized ratio (INR) >2.5
  • Long-term (>2 weeks) use of antibiotics in the past 3 months
  • Pregnant or attempting to get pregnant
  • Sites with probing depth > 4mm
  • Recession adjacent to an edentulous area

Frenal and muscle attachment that encroach on the marginal gingiva

a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy)

  • History of periodontal surgical treatment of the involved sites
  • Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth
  • Teeth with pulpal pathology
  • Severe teeth malposition and open contacts
  • Planned orthodontic treatment to commence within 1 year following procedure
  • Parafunctional habits -

Trial design

42 participants in 2 patient groups

1mm thick graft
Active Comparator group
Description:
connective tissue graft of 1mm thickness
Treatment:
Procedure: connective tissue graft
2mm thick graft
Active Comparator group
Description:
connective tissue graft of 2mm thickness
Treatment:
Procedure: connective tissue graft

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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