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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Tunnel technique

Connective tissue graft

Concentrated growth factor membrane

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bulent Ecevit U.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TT+CTG

TT+CGF

Arm Description

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

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

Outcomes

Primary Outcome Measures

Complete root coverage

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

Secondary Outcome Measures

Mean root coverage

Change from baseline in percentage of root coverage at 6th 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

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

Gingival recession depth

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

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

Keratinized tissue width

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

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

Full Information

NCT ID

NCT04561947

First Posted

September 20, 2020

Last Updated

September 20, 2020

Sponsor

Bulent Ecevit University

1. Study Identification

Unique Protocol Identification Number

NCT04561947

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

July 30, 2018 (Actual)

Study Completion Date

July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bulent Ecevit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TT+CTG

Arm Type

Active Comparator

Arm Description

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

Arm Title

TT+CGF

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Tunnel technique

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Connective tissue graft

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Concentrated growth factor membrane

Intervention Description

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.

Primary Outcome Measure Information:

Title

Complete root coverage

Description

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

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Mean root coverage

Description

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

Time Frame

Six months

Title

Probing depth

Description

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

Title

Clinical attachment level

Description

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

Title

Gingival recession depth

Description

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

Time Frame

Six months

Title

Gingival recession width

Description

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

Title

Keratinized tissue width

Description

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

Time Frame

Six months

Title

Gingival thickness

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Birsen KORKMAZ, assis. Prof.

Organizational Affiliation

birsenkorkmaz91@gmail.com

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Umut BALLI, Assoc. Prof.

Organizational Affiliation

ZBEU.

Official's Role

Study Director

Facility Information:

Facility Name

Bulent Ecevit U.

City

Zonguldak

ZIP/Postal Code

67600

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33830339

Citation

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.

Results Reference

derived

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

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