CGF: Surgical Treatment With Concentrated Growth Factor for Multiple Papillary Losses

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT03635931
Collaborator
Ankara University (Other)
40
1
2
12.4
3.2

Study Details

Study Description

Brief Summary

The aim of this study was to evaluate the efficacy of concentrated growth factor (CGF) in applied in the regenerative treatment of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.This controlled, examiner-blinded, clinical study included of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). Then patients were randomly assigned to receive surgical regenerative periodontal treatment(test) or periodontal care(control)The test group was formed of 20 patients with 60 adjacent papillary defects . A control group was formed of 20 patients with 60 adjacent papillary defects.. A total of 480 images obtained with the digital impressions . Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and mean platelet volume values(MPV) were recorded.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Concentrated Growth Factor
N/A

Detailed Description

The treatment of open gingival embrasures, which are also known as black triangles (BT) or black holes, and cause esthetic, functional and phonetic problems in the anterior region, has become an area of interest in current periodontal treatment.Surgical, non-surgical and prosthetic methods are applied in the treatment of BT, which can be seen in more than half of adults. This study aimed to evaluate the efficacy of concentrated growth factor (CGF) in regenerating interdental papillary of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.

This controlled, examiner-blinded, randomized clinical study included 160 teeth of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). The test group was formed of 20 patients with 60 adjacent papillary defects undergoing minimally invasive surgery for papillary regeneration with CGF. A control group was formed of 20 patients with 60 adjacent papillary defects who were not included surgical treatment. A total of 480 images obtained with the digital impressions method of each interdental papillary region in each patient were uploaded to a special software. Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated between the two central teeth, between the lateral and central teeth, and between the lateral and canine teeth prior to the treatment and at pro-treatment periods of 3, 6 and 12 months in both of the groups. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and MPV values were recorded.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The test and control group was formed of patients with adjacent papillary defects In test group, elective minimally invasive surgery for papillary regeneration with CGF was performed. A control group was formed of patients with adjacent papillary defects who were not included to have surgical treatment.The test and control group was formed of patients with adjacent papillary defects In test group, elective minimally invasive surgery for papillary regeneration with CGF was performed. A control group was formed of patients with adjacent papillary defects who were not included to have surgical treatment.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficiency of Concentrated Growth Factor in the Surgical Treatment of Multiple Adjacent Papillary Losses: a Controlled, Examiner-blinded Clinical Study
Actual Study Start Date :
Jul 30, 2017
Actual Primary Completion Date :
Jul 30, 2018
Actual Study Completion Date :
Aug 12, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Concentrated Growth Factor

plaque control, scaling and root planing if required, surgical application of CGF

Procedure: Concentrated Growth Factor
surgical treatment with CGF for papilla regeneration

No Intervention: Control Group

plaque control, scaling and root planing if required

Outcome Measures

Primary Outcome Measures

  1. change in the percentage of papillary fill(PF) [Change from 3 months percentage of papillary fill at 6 months]

    The percentage of PF was also calculated as ([ Lost Papillary area(PA) preoperation - PA postoperation] / PA preoperation) x 100%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Clinical diagnosis of interdental papillary losses in the maxillary anterior teeth, between the adjacent central teeth, the central and lateral teeth and the lateral and canine teeth

  • The presence of a contact point in the maxillary anterior teeth

  • optimal facial keratinized gingiva/ keratinized gingiva must be more than 2mm

Exclusion Criteria:
  • pregnancy or

  • breast-feeding,

  • palatal and gingival recession,

  • attachment loss,

  • high labial frenulum.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gazi University Faculty of Dentistry Department of Periodontology Ankara Çankaya Turkey 06510

Sponsors and Collaborators

  • Gazi University
  • Ankara University

Investigators

  • Principal Investigator: zeynep Turgut Çankaya, PhD,Dr, Gazi University, Faculty of Dentistry,Department of Periodontology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeynep Turgut Çankaya, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier:
NCT03635931
Other Study ID Numbers:
  • 36290600
First Posted:
Aug 17, 2018
Last Update Posted:
Jul 30, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeynep Turgut Çankaya, Principal Investigator, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2019