Gingival RecessionNCT04561947
Treatment of Gingival Recessions with Connective Tissue or Concentrated Growth Factor Membrane Using Tunnel Technique
A study testing Tunnel technique, Connective tissue graft and Concentrated growth factor membrane in people with Gingival Recession, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tunnel technique, Connective tissue graft and Concentrated growth factor membrane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2017to 30 Jul 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Recession
- Being tested
- Tunnel technique, Connective tissue graft, Concentrated growth factor membrane
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunnel techniqueProcedure or surgery
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.
Connective tissue graftProcedure or surgery
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.
Concentrated growth factor membraneOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TT+CTG | Active comparator | The combined connective tissue graft (CTG) with tunnel technique (TT) Receives: Procedure: Tunnel technique; Procedure: Connective tissue graft |
| TT+CGF | Experimental | The combined concentrated growth factor (CGF) membrane with tunnel technique (TT) Receives: Procedure: Tunnel technique; Other: Concentrated growth factor membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete root coverage
Change from baseline in percentage of complete root coverage at 6th months.
Measured: Six months
Secondary outcomes (7)
Mean root coverage
Change from baseline in percentage of root coverage at 6th months.
Measured: Six months
Probing depth
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
Measured: Six months
Clinical attachment level
The changes in clinical attachment level after 6th months. Distance between the sulcus base and the CEJ in the midbuccal aspect of the teeth
Measured: Six months
Gingival recession depth
The changes in gingival recession depth after 6th months. Distance between the gingival margin at the deepest point of recession
Measured: Six months
Gingival recession width
The changes in gingival recession width after 6th months. Horizontal distance between the mesial and distal margin of the recession defect at the CEJ
Measured: Six months
Keratinized tissue width
The changes in keratinized tissue width after 6th months. Distance between the gingival margin and the mucogingival junction
Measured: Six months
Gingival thickness
The changes in gingival thickness after 6th months. Measured midbuccally from 2 mm apical to the gingival margin with a No: 20 endodontic spreader
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut BALLI, Bulent Ecevit University
- Investigators
- Birsen KORKMAZ, assis. Prof., Principal investigator, birsenkorkmaz91@gmail.comUmut BALLI, Assoc. Prof., Study director, ZBEU.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561947
- Sponsor's protocol ID
- 2017-82-09/08
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korkmaz B, Balli U. Clinical evaluation of the treatment of multiple gingival recessions with connective tissue graft or concentrated growth factor using tunnel technique: a randomized controlled clinical trial. Clin Oral Investig. 2021 Nov;25(11):6347-6356. doi: 10.1007/s00784-021-03935-3. Epub 2021 Apr 8.
PubMed 33830339
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04561947
- Acronym / sponsor ID
- 2017-82-09/08
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 24 Sep 2020 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT+CTG | Active comparator | Procedure: Tunnel technique, Procedure: Connective tissue graftThe combined connective tissue graft (CTG) with tunnel technique (TT) |
| TT+CGF | Experimental | Procedure: Tunnel technique, Other: Concentrated growth factor membraneThe combined concentrated growth factor (CGF) membrane with tunnel technique (TT) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Tunnel techniqueAfter 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. | Procedure or surgery | TT+CGF, TT+CTG |
| Connective tissue graftCTG 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. | Procedure or surgery | TT+CTG |
| Concentrated growth factor membraneIntravenous 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. | Other | TT+CGF |
Primary outcome
Complete root coverage
Time frame: Six months
Change from baseline in percentage of complete root coverage at 6th months.
7 secondary outcomes
Mean root coverage
Time frame: Six months
Probing depth
Time frame: Six months
Clinical attachment level
Time frame: Six months
Gingival recession depth
Time frame: Six months
Gingival recession width
Time frame: Six months
Keratinized tissue width
Time frame: Six months
Gingival thickness
Time frame: Six 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 6 Feb 2025.
- Derived from this study: PubMed 33830339Korkmaz B, Balli U. Clinical evaluation of the treatment of multiple gingival recessions with connective tissue graft or concentrated growth factor using tunnel technique: a randomized controlled clinical trial. Clin Oral Investig. 2021 Nov;25(11):6347-6356. doi: 10.1007/s00784-021-03935-3. Epub 2021 Apr 8.
- Individual participant dataSharing planned: No
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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.
Birsen KORKMAZ, assis. Prof. principal investigator
birsenkorkmaz91@gmail.com
Umut BALLI, Assoc. Prof. study director
ZBEU.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunnel technique, Connective tissue graft and Concentrated growth factor membrane in people with Gingival Recession, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Complete root coverage (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04561947, which also lists 1 linked publication.
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 6 Feb 2025.