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

NCT03032094 | Completed

• 1 other identifier: AAAN2667
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gingival Recession

Keywords

Gingival Recession

Outcome Measures

Primary Outcomes (4)

• Root coverage

  Amount of root coverage attained in millimeters

  Upto 3 months

• Root coverage

  Amount of root coverage attained in percentage

  Upto 3 months

• width of keratinized tissue

  Amount of zone of keratinized tissue attained in millimeters

  Upto 3 months

• width of keratinized tissue

  Amount of zone of keratinized tissue attained in percentage

  Upto 3 months

Secondary Outcomes (3)

• thickness of keratinized tissue

  Upto 3 months

• amount of erythema and edema

  Upto 3 months

• duration of erythema and edema

  Upto 3 months

Study Arms (2)

1mm thick graft

ACTIVE COMPARATOR

connective tissue graft of 1mm thickness

Procedure: connective tissue graft

2mm thick graft

ACTIVE COMPARATOR

connective tissue graft of 2mm thickness

Procedure: connective tissue graft

Interventions

connective tissue graft PROCEDURE

palatal connective tissue graft to attain root coverage

1mm thick graft; 2mm thick graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) -

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Evanthia Lalla, DDS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dental Medicine (Periodontics)

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 26, 2017
• Study Start: October 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01