Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects

NCT02836314 | Completed

• 1 other identifier: 03/10-12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this split mouth, single-center, controlled study is to compare the healing of intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.

Conditions

Chronic Periodontitis; Intrabony Periodontal Defect

Keywords

Anorganic bovine bone mineral;; Graft; Intrabony periodontal defect; platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level change: The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively

  baseline and 6 months

Secondary Outcomes (3)

• Vertical bone loss change: Distance between cemento-enamel junction and base of the defect measured in standardized radiographs at baseline and 6 months postoperatively

  Baseline and 6 months

• Probing depth change: The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively

  baseline and 6 months

• Radiographic defect angle change: Using the function 'angle' the defect angle can be measured by assessing the two lines that represent the root surface of the involved tooth and the bone defect surface at baseline and 6 months postoperatively

  baseline and 6 months

Study Arms (2)

PRF and ABBM

EXPERIMENTAL

Intervention: Anorganic Bovine Bone Mineral and Platelet Rich fibrin is applied to the periodontal intrabony defects

Other: Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)

Anorganic Bovine Bone Mineral

ACTIVE COMPARATOR

Intervention: Anorganic Bovine Bone Mineral is applied to the periodontal intrabony defects

Other: Anorganic Bovine Bone Mineral (ABBM)

Interventions

Anorganic Bovine Bone Mineral (ABBM) OTHER

In the control group, periodontal intrabony defects were treated with ABBM alone.

Anorganic Bovine Bone Mineral

Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF) OTHER

In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.

PRF and ABBM

Eligibility Criteria

• Age: 38 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• no systemic diseases;
• a good level of oral hygiene (OH) (plaque index\<0.15);
• presence of two paired two-wall or three-wall intrabony defects with probing depth ≥6mm and an intrabony component ≥3mm as detected on radiographs; -no intrabony defects extending into the furcation area;
• tooth mobility ≤1;
• tooth and adjoining teeth testing vital and without symptoms or signs of endodontic involvement;
• tooth and adjoining teeth free of caries or inadequate restorations.

You may not qualify if:

• patients with compromised immune systems;
• pregnant and/or lactating women;
• patients taking any drug known to affect the periodontal status or affect the coagulation system
• smokers.

Sponsors & Collaborators

• Baskent University: lead
• Gazi University: collaborator

Study Sites (1)

Yasemin Sezgin

Ankara, 06540, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Levent Taner, PhD, DDS

  Gazi University, Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 19, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)