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

NCT04561947 | Completed

• 1 other identifier: 2017-82-09/08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Complete root coverage

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

  Six months

Secondary Outcomes (7)

• Mean root coverage

  Six months

• Probing depth

  Six months

• Clinical attachment level

  Six months

• Gingival recession depth

  Six months

• Gingival recession width

  Six months

Study Arms (2)

TT+CTG

ACTIVE COMPARATOR

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

Procedure: Tunnel technique; Procedure: Connective tissue graft

TT+CGF

EXPERIMENTAL

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

Procedure: Tunnel technique; Other: Concentrated growth factor membrane

Interventions

Tunnel technique PROCEDURE

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.

TT+CGF; TT+CTG

Connective tissue graft PROCEDURE

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.

TT+CTG

Concentrated growth factor membrane OTHER

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.

TT+CGF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Bulent Ecevit U.

Zonguldak, 67600, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33830339 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Birsen KORKMAZ, assis. Prof.

  birsenkorkmaz91@gmail.com

  PRINCIPAL INVESTIGATOR

• Umut BALLI, Assoc. Prof.

  ZBEU.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: February 6, 2025

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)