Surgical Treatment With Concentrated Growth Factor for Multiple Papillary Losses

NCT03635931 | Completed

• 1 other identifier: 36290600
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Papilla, Dentinal; Calcification

Keywords

CGF; lost interdental papilla

Outcome Measures

Primary Outcomes (1)

• 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%.

  Change from 3 months percentage of papillary fill at 6 months

Study Arms (2)

Concentrated Growth Factor

ACTIVE COMPARATOR

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

Procedure: Concentrated Growth Factor

Control Group

NO INTERVENTION

plaque control, scaling and root planing if required

Interventions

Concentrated Growth Factor PROCEDURE

surgical treatment with CGF for papilla regeneration

Concentrated Growth Factor

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• pregnancy or
• breast-feeding,
• palatal and gingival recession,
• attachment loss,
• high labial frenulum.

Sponsors & Collaborators

• Gazi University: lead
• Ankara University: collaborator

Study Sites (1)

Gazi University Faculty of Dentistry Department of Periodontology

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• zeynep Turgut Çankaya, PhD,Dr

  Gazi University, Faculty of Dentistry,Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: July 30, 2017
• Primary Completion: July 30, 2018
• Study Completion: August 12, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)