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Completed

NCT Number: NCT02836314

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

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.

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Key information

Age range

38 year–61 year

Study type

Interventional

Phase

Not applicable

Primary location

Yasemin Sezgin

Ankara, 06540, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anorganic Bovine Bone Mineral (ABBM)

Other

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

Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)

Other

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

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

    Time frame: baseline and 6 months

Secondary outcomes

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

    Time frame: Baseline and 6 months

  2. 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

    Time frame: baseline and 6 months

  3. 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

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

  • Gazi University

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2016
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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