- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04561947
Treatment of Gingival Recessions With Connective Tissue or Concentrated Growth Factor Membrane Using Tunnel Technique
September 20, 2020 updated by: Umut BALLI, Bulent Ecevit University
Clinical Evaluation of the Treatment of Multiple Gingival Recessions With Connective Tissue Graft or Concentrated Growth Factor Membrane Using Tunnel Technique: A Randomized Controlled Clinical Trial
This randomized controlled clinical study aimed to evaluate the success of the combination of tunnel technique and concentrated growth factor membrane for root coverage in treating multiple gingival recessions and compare with the gold standard connective tissue graft.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study included 108 defects in 40 patients with Miller Class I and II gingival recession.
Gingival recession defects were randomly divided into two groups.
Tunnel technique + connective tissue graft was applied to 20 patients in the control group (51 defects) and tunnel technique + concentrated growth factor membrane was applied to 20 patients in the test group (57 defects).
The results at baseline and 6 months were evaluated for the following clinical parameters: Mean root coverage, complete root coverage, probing depth, clinical attachment level, gingival recession depth, gingival recession width, keratinized tissue width and gingival thickness.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zonguldak, Turkey, 67600
- Bulent Ecevit U.
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age ≥18 years
- periodontally and systemically healthy
- presence of Miller I or II class gingival recession defect in at least two teeth on the buccal aspect of incisors, canine and premolar teeth (≥ 2 mm in depth)
- gingival thickness ≥ 0.8 mm 2 mm apical to the gingival margin
- presence of identifiable cementoenamel junction (CEJ) (step ≤1 mm at the CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ was accepted
- full-mouth plaque score (FMPS) ≤20%.
Exclusion Criteria:
- smoking
- contraindications for surgical periodontal treatment
- presence of recession defects associated caries, restoration and furcation problems
- use of systemic antibiotics for any reason in the last 3 months.
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: TT+CTG
The combined connective tissue graft (CTG) with tunnel technique (TT)
|
After local anesthesia, the exposed root surfaces were mechanically treated with curettes.
A tunnelling knives were used to prepare a split-thickness flap and create a continuous tunnel in the buccal soft tissues, following the intrasulcular incision with a #69 microblade.
Split-thickness flap preparation was performed to beyond the mucogingival junction with supraperiosteal dissection by placing the tunneling knives to the soft tissue.
This process was repeated by entering through the sulcus of each tooth.
After the elevation of the flap, a papilla elevator placed under the flap was entered through the sulcus to mobilize the papilla, the periosteum at the base of the papilla was cut, and the full-thickness flap was elevated.
CTG was harvested using the de-epithelialized connective tissue graft technique.
The epithelial tissue on the outer surface of the graft was removed with a 15 blade and a 1-mm-thick graft was obtained.
|
Experimental: TT+CGF
The combined concentrated growth factor (CGF) membrane with tunnel technique (TT)
|
After local anesthesia, the exposed root surfaces were mechanically treated with curettes.
A tunnelling knives were used to prepare a split-thickness flap and create a continuous tunnel in the buccal soft tissues, following the intrasulcular incision with a #69 microblade.
Split-thickness flap preparation was performed to beyond the mucogingival junction with supraperiosteal dissection by placing the tunneling knives to the soft tissue.
This process was repeated by entering through the sulcus of each tooth.
After the elevation of the flap, a papilla elevator placed under the flap was entered through the sulcus to mobilize the papilla, the periosteum at the base of the papilla was cut, and the full-thickness flap was elevated.
Intravenous blood samples were collected in without anticoagulant 10-mL tubes and immediately centrifuged in a CGF centrifuge machine using a program with the following features: 30 ̋ acceleration, 2 min at 2700 rpm, 4 min at 2400 rpm, 4 min at 2700 rpm, 3 min at 3000 rpm, and 36 ̋ deceleration and stop.
After centrifugation, four layers were formed in the tube: the serum layer at the top, the second buffy coat layer, the third CGF layer containing GF and unipotent stem cells, and the red blood cell layer at the bottom.
The resulting CGF was removed from the tube and separated from the red blood cell layer using microsurgical scissors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete root coverage
Time Frame: Six months
|
Change from baseline in percentage of complete root coverage at 6th months.
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean root coverage
Time Frame: Six months
|
Change from baseline in percentage of root coverage at 6th months.
|
Six months
|
Probing depth
Time Frame: Six months
|
Change from baseline in probing depth at 6th months.
The distance between the sulcus base and the gingival margin the midbuccal aspect of the teeth
|
Six months
|
Clinical attachment level
Time Frame: Six months
|
The changes in clinical attachment level after 6th months.
Distance between the sulcus base and the CEJ in the midbuccal aspect of the teeth
|
Six months
|
Gingival recession depth
Time Frame: Six months
|
The changes in gingival recession depth after 6th months.
Distance between the gingival margin at the deepest point of recession
|
Six months
|
Gingival recession width
Time Frame: Six months
|
The changes in gingival recession width after 6th months.
Horizontal distance between the mesial and distal margin of the recession defect at the CEJ
|
Six months
|
Keratinized tissue width
Time Frame: Six months
|
The changes in keratinized tissue width after 6th months.
Distance between the gingival margin and the mucogingival junction
|
Six months
|
Gingival thickness
Time Frame: Six months
|
The changes in gingival thickness after 6th months.
Measured midbuccally from 2 mm apical to the gingival margin with a No: 20 endodontic spreader
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Birsen KORKMAZ, assis. Prof., birsenkorkmaz91@gmail.com
- Study Director: Umut BALLI, Assoc. Prof., ZBEU.
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)
October 1, 2017
Primary Completion (Actual)
July 30, 2018
Study Completion (Actual)
July 30, 2018
Study Registration Dates
First Submitted
September 20, 2020
First Submitted That Met QC Criteria
September 20, 2020
First Posted (Actual)
September 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 24, 2020
Last Update Submitted That Met QC Criteria
September 20, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-82-09/08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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