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CompletedNCT04561947Updated Feb 6, 2025

Treatment of Gingival Recessions with Connective Tissue or Concentrated Growth Factor Membrane Using Tunnel Technique

An interventional study of Tunnel technique and Connective tissue graft in Gingival Recession, sponsored by Bulent Ecevit University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Bulent Ecevit University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Oct 2017, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gingival Recession

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03

In context

Gingival Recession

402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's enrollment of 40 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Bulent Ecevit University is the lead sponsor of 45 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    TT+CTG

    The combined connective tissue graft (CTG) with tunnel technique (TT)

    Procedure: Tunnel technique · Procedure: Connective tissue graft

  • Experimental
    TT+CGF

    The combined concentrated growth factor (CGF) membrane with tunnel technique (TT)

    Procedure: Tunnel technique · Other: Concentrated growth factor membrane

Interventions

  • ProcedureTunnel technique

    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.

  • ProcedureConnective tissue graft

    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.

  • OtherConcentrated growth factor membrane

    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.

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What researchers measure

Primary outcomes

  1. Complete root coverage

    Change from baseline in percentage of complete root coverage at 6th months.

    Time frame: Six months

Secondary outcomes

  1. Mean root coverage

    Change from baseline in percentage of root coverage at 6th months.

    Time frame: Six months

  2. 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

    Time frame: Six months

  3. 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

    Time frame: Six months

  4. Gingival recession depth

    The changes in gingival recession depth after 6th months. Distance between the gingival margin at the deepest point of recession

    Time frame: Six months

  5. 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

    Time frame: Six months

  6. Keratinized tissue width

    The changes in keratinized tissue width after 6th months. Distance between the gingival margin and the mucogingival junction

    Time frame: Six months

  7. 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

    Time frame: Six months

07

Study locations

1 site
  • Bulent Ecevit U.
    Zonguldak, 67600, Turkey
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04561947
Lead sponsor
Bulent Ecevit University
Responsible party
Umut BALLI (Associate professor, Bulent Ecevit University) — Principal investigator
First posted
Sep 24, 2020
Start date
Oct 1, 2017
Primary completion
Jul 30, 2018
Completion
Jul 30, 2018
Last update
Feb 6, 2025

Study contacts

Birsen KORKMAZ, assis. Prof.
principal investigator · birsenkorkmaz91@gmail.com
Umut BALLI, Assoc. Prof.
study director · ZBEU.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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