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

Chronic Periodontitis Clinical Trial

Official title:

Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Defects Treated With Anorganic Bovine Bone Mineral: A Randomized Clinical and Radiological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836314
• Other study ID #: 03/10-12
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: July 14, 2016
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2016
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Anorganic bovine bone mineral (ABBM) is extensively used in the treatment of intrabony defects. Platelet rich fibrin (PRF) is a new generation platelet concentrate with a simplified technique. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate its additive effects with ABBM. Therefore, a randomized, split mouth clinical trial was conducted to compare the healing of intrabony defects treated with a PRF/ABBM combination and to those obtained with ABBM alone. Using a split mouth design, 15 paired intrabony defects were randomly treated with either ABBM alone (control group) or with ABBM- PRF combination (test group). The following clinical parameters and radiographic measurements were recorded at baseline and six months postoperatively: plaque index (PI), gingival index (GI), probing depth (PD), gingival recession (GR), clinical attachment level (CAL), vertical bone loss, the depth of the defect and defect angle

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 38 Years to 61 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Intrabony Periodontal Defect
• Periodontitis

Intervention

Other:
• Anorganic Bovine Bone Mineral (ABBM)
In the control group, periodontal intrabony defects were treated with ABBM alone.
• Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.

Locations

Country	Name	City	State
Turkey	Yasemin Sezgin	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Baskent University	Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No