Clinical trial NCT02836314: Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Intrabony Periodontal Defect
Keywords: Anorganic bovine bone mineral;
Graft
Intrabony periodontal defect
platelet rich fibrin
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2016-07-19
Enrollment: 15
Minimum age (years): 38
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Vertical bone loss change: Distance between cemento-enamel junction and base of the defect measured in standardized radiographs at baseline and 6 months postoperatively
timeFrame: Baseline and 6 months
measure: 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
timeFrame: baseline and 6 months
measure: 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
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yasemin Sezgin
Study officials:
affiliation: Gazi University, Faculty of Dentistry, Department of Periodontology
name: Levent Taner, PhD, DDS
role: STUDY_DIRECTOR
References: