Gingival RecessionNCT03032094
Connective Tissue Grafting for Single Tooth Recession & the Impact of the Thickness of the Palatal Harvest Tissue
A study testing connective tissue graft in people with Gingival Recession, run by Columbia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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) -
Who cannot join
- 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
Show all 17Show fewer
- 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
- 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 -
About this study
Official title: Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study
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.
Read the 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.
- Conditions
- Gingival Recession
- Being tested
- connective tissue graft
- Keywords
- Gingival Recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graftProcedure or surgery
palatal connective tissue graft to attain root coverage
| Study group | Role | What they receive |
|---|---|---|
| 1mm thick graft | Active comparator | connective tissue graft of 1mm thickness Receives: Procedure: connective tissue graft |
| 2mm thick graft | Active comparator | connective tissue graft of 2mm thickness Receives: Procedure: connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root coverage
Amount of root coverage attained in millimeters
Measured: Upto 3 months
Root coverage
Amount of root coverage attained in percentage
Measured: Upto 3 months
width of keratinized tissue
Amount of zone of keratinized tissue attained in millimeters
Measured: Upto 3 months
width of keratinized tissue
Amount of zone of keratinized tissue attained in percentage
Measured: Upto 3 months
Secondary outcomes (3)
thickness of keratinized tissue
Measured: Upto 3 months
amount of erythema and edema
patient reported outcome of amount of erythema and edema in number of days postoperatively
Measured: Upto 3 months
duration of erythema and edema
patient reported outcome of duration of erythema and edema in number of days postoperatively
Measured: Upto 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evanthia Lalla, Columbia University
- Investigators
- Evanthia Lalla, DDS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032094
- Sponsor's protocol ID
- AAAN2667
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Grafting for Single Tooth Recession Defects & the Impact of the Thickness of the Palatal Harvest Tissue: A Pilot Study
- ClinicalTrials.gov ID
- NCT03032094
- Acronym / sponsor ID
- AAAN2667
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1mm thick graft | Active comparator | Procedure: connective tissue graftconnective tissue graft of 1mm thickness |
| 2mm thick graft | Active comparator | Procedure: connective tissue graftconnective tissue graft of 2mm thickness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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) -
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| connective tissue graftpalatal connective tissue graft to attain root coverage | Procedure or surgery | 1mm thick graft, 2mm thick graft |
Primary outcome
Root coverage
Time frame: Upto 3 months
Amount of root coverage attained in millimeters
Root coverage
Time frame: Upto 3 months
Amount of root coverage attained in percentage
width of keratinized tissue
Time frame: Upto 3 months
Amount of zone of keratinized tissue attained in millimeters
width of keratinized tissue
Time frame: Upto 3 months
Amount of zone of keratinized tissue attained in percentage
3 secondary outcomes
thickness of keratinized tissue
Time frame: Upto 3 months
amount of erythema and edema
Time frame: Upto 3 months
duration of erythema and edema
Time frame: Upto 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Recession
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evanthia Lalla, DDS principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing connective tissue graft in people with Gingival Recession, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root coverage (time frame: Upto 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.