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Surgical Treatment With Concentrated Growth Factor for Multiple Papillary Losses (CGF)

Primary Purpose

Papilla, Dentinal; Calcification

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Concentrated Growth Factor
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papilla, Dentinal; Calcification focused on measuring CGF, lost interdental papilla

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gazi University Faculty of Dentistry Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Concentrated Growth Factor

Control Group

Arm Description

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

plaque control, scaling and root planing if required

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 13, 2018
Last Updated
July 29, 2019
Sponsor
Gazi University
Collaborators
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT03635931
Brief Title
Surgical Treatment With Concentrated Growth Factor for Multiple Papillary Losses
Acronym
CGF
Official Title
Efficiency of Concentrated Growth Factor in the Surgical Treatment of Multiple Adjacent Papillary Losses: a Controlled, Examiner-blinded Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 30, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papilla, Dentinal; Calcification
Keywords
CGF, lost interdental papilla

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concentrated Growth Factor
Arm Type
Active Comparator
Arm Description
plaque control, scaling and root planing if required, surgical application of CGF
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
plaque control, scaling and root planing if required
Intervention Type
Procedure
Intervention Name(s)
Concentrated Growth Factor
Intervention Description
surgical treatment with CGF for papilla regeneration
Primary Outcome Measure Information:
Title
change in the percentage of papillary fill(PF)
Description
The percentage of PF was also calculated as ([ Lost Papillary area(PA) preoperation - PA postoperation] / PA preoperation) x 100%.
Time Frame
Change from 3 months percentage of papillary fill at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeynep Turgut Çankaya, PhD,Dr
Organizational Affiliation
Gazi University, Faculty of Dentistry,Department of Periodontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University Faculty of Dentistry Department of Periodontology
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06510
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Surgical Treatment With Concentrated Growth Factor for Multiple Papillary Losses

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