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

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ClinicalTrials.gov Identifier: NCT03032094
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Evanthia Lalla, Columbia University

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.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: connective tissue graft Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study
Study Start Date : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: 1mm thick graft
connective tissue graft of 1mm thickness
Procedure: connective tissue graft
palatal connective tissue graft to attain root coverage

Active Comparator: 2mm thick graft
connective tissue graft of 2mm thickness
Procedure: connective tissue graft
palatal connective tissue graft to attain root coverage




Primary Outcome Measures :
  1. Root coverage [ Time Frame: Upto 3 months ]
    Amount of root coverage attained in millimeters

  2. Root coverage [ Time Frame: Upto 3 months ]
    Amount of root coverage attained in percentage

  3. width of keratinized tissue [ Time Frame: Upto 3 months ]
    Amount of zone of keratinized tissue attained in millimeters

  4. width of keratinized tissue [ Time Frame: Upto 3 months ]
    Amount of zone of keratinized tissue attained in percentage


Secondary Outcome Measures :
  1. thickness of keratinized tissue [ Time Frame: Upto 3 months ]
  2. amount of erythema and edema [ Time Frame: Upto 3 months ]
    patient reported outcome of amount of erythema and edema in number of days postoperatively

  3. duration of erythema and edema [ Time Frame: Upto 3 months ]
    patient reported outcome of duration of erythema and edema in number of days postoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032094


Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Evanthia Lalla, DDS Columbia University
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Responsible Party: Evanthia Lalla, Professor of Dental Medicine (Periodontics), Columbia University
ClinicalTrials.gov Identifier: NCT03032094    
Other Study ID Numbers: AAAN2667
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evanthia Lalla, Columbia University:
Gingival Recession
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy