- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04109794
Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
September 27, 2019 updated by: H. Gencay Keceli, Kırıkkale University
42 patients were treated either with E-CTG (N=20) or SCAF (N=22).
The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- single Miller I GR defects ≤3mm at upper anterior or premolar teeth
- systemically healthy
- identifiable cemento-enamel junction (CEJ)
- PD ≤3 mm
Exclusion Criteria:
- periodontal surgery experience in the past two years
- excessive contacts
- mobility
- caries
- loss of vitality
- smoking
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: E-CTG
Envelope connective tissue graft
|
Envelope connective tissue graft
|
Active Comparator: SCAF
Semilunar connective tissue graft
|
Envelope connective tissue graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recession depth
Time Frame: baseline
|
Distance between CEJ and GM
|
baseline
|
recession depth
Time Frame: 6 weeks
|
Distance between CEJ and GM
|
6 weeks
|
recession depth
Time Frame: 6 months
|
Distance between CEJ and GM
|
6 months
|
recession depth
Time Frame: 12 months
|
Distance between CEJ and GM
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recession width
Time Frame: baseline
|
horizontal distance between two borders of recession at CEJ level
|
baseline
|
recession width
Time Frame: 6 weeks
|
horizontal distance between two borders of recession at CEJ level
|
6 weeks
|
recession width
Time Frame: 6 months
|
horizontal distance between two borders of recession at CEJ level
|
6 months
|
recession width
Time Frame: 12 months
|
horizontal distance between two borders of recession at CEJ level
|
12 months
|
probing depth
Time Frame: baseline
|
distance between GM and base of gingival sulcus
|
baseline
|
probing depth
Time Frame: 6 weeks
|
distance between GM and base of gingival sulcus
|
6 weeks
|
probing depth
Time Frame: 6 months
|
distance between GM and base of gingival sulcus
|
6 months
|
probing depth
Time Frame: 12 months
|
distance between GM and base of gingival sulcus
|
12 months
|
clinical attachment level
Time Frame: baseline
|
distance between CEJ and base of gingival sulcus
|
baseline
|
clinical attachment level
Time Frame: 6 weeks
|
distance between CEJ and base of gingival sulcus
|
6 weeks
|
clinical attachment level
Time Frame: 6 months
|
distance between CEJ and base of gingival sulcus
|
6 months
|
clinical attachment level
Time Frame: 12 months
|
distance between CEJ and base of gingival sulcus
|
12 months
|
keratinized tissue width
Time Frame: baseline
|
distance between GM and MGJ
|
baseline
|
keratinized tissue width
Time Frame: 6 weeks
|
distance between GM and MGJ
|
6 weeks
|
keratinized tissue width
Time Frame: 6 months
|
distance between GM and MGJ
|
6 months
|
keratinized tissue width
Time Frame: 12 months
|
distance between GM and MGJ
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (Actual)
September 30, 2019
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 27, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SerdarEvginer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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