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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

connective tissue graft

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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 -

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1mm thick graft

2mm thick graft

Arm Description

connective tissue graft of 1mm thickness

connective tissue graft of 2mm thickness

Outcomes

Primary Outcome Measures

Root coverage

Amount of root coverage attained in millimeters

Root coverage

Amount of root coverage attained in percentage

width of keratinized tissue

Amount of zone of keratinized tissue attained in millimeters

width of keratinized tissue

Amount of zone of keratinized tissue attained in percentage

Secondary Outcome Measures

thickness of keratinized tissue

amount of erythema and edema

patient reported outcome of amount of erythema and edema in number of days postoperatively

duration of erythema and edema

patient reported outcome of duration of erythema and edema in number of days postoperatively

Full Information

NCT ID

NCT03032094

First Posted

January 11, 2017

Last Updated

January 24, 2017

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT03032094

Brief Title

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

Official Title

Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

Gingival Recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1mm thick graft

Arm Type

Active Comparator

Arm Description

connective tissue graft of 1mm thickness

Arm Title

2mm thick graft

Arm Type

Active Comparator

Arm Description

connective tissue graft of 2mm thickness

Intervention Type

Procedure

Intervention Name(s)

connective tissue graft

Intervention Description

palatal connective tissue graft to attain root coverage

Primary Outcome Measure Information:

Title

Root coverage

Description

Amount of root coverage attained in millimeters

Time Frame

Upto 3 months

Title

Root coverage

Description

Amount of root coverage attained in percentage

Time Frame

Upto 3 months

Title

width of keratinized tissue

Description

Amount of zone of keratinized tissue attained in millimeters

Time Frame

Upto 3 months

Title

width of keratinized tissue

Description

Amount of zone of keratinized tissue attained in percentage

Time Frame

Upto 3 months

Secondary Outcome Measure Information:

Title

thickness of keratinized tissue

Time Frame

Upto 3 months

Title

amount of erythema and edema

Description

patient reported outcome of amount of erythema and edema in number of days postoperatively

Time Frame

Upto 3 months

Title

duration of erythema and edema

Description

patient reported outcome of duration of erythema and edema in number of days postoperatively

Time Frame

Upto 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evanthia Lalla, DDS

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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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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