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Completed

NCT Number: NCT05886699

Comparison of PRP & DFDBA vs. DFDBA in Intrabony Periodontal Defects

The purpose of this clinical trial is to compare the results in subjects with periodontitis using subjects own blood - Platelet-rich plasma (PRP) combined with bone graft material, namely, Demineralized Freeze - Dried Bone Allograft (DFDBA) or DFDBA alone in the treatment of bone defects around the teeth.

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Key information

Conditions

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

Age range

28 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

212, Department of Periodontology, Government Dental college and Hospital

Nagpur, Maharashtra, 440003, India

About this study

After being informed about the study and potential risks, 13 patients giving written informed consent and who meet the eligibility requirements were randomly allocated in a single blind manner (participants) to test group (PRP combined with DFDBA) or control group (DFDBA).

33 sites (18 test, 15 control unpaired defects) were treated - 1) to investigate the possible additional effects of PRP when combined with DFDBA, and 2) to compare the clinical and radiographic outcomes obtained in test and control groups,12 months post - operatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatients
  • with chronic periodontitis
  • who were free of local or systemic disease
  • who had not received any type of periodontal therapy in the last six months
  • radiograph showing at least one angular defect in any quadrant
  • the involved teeth were vital and asymptomatic
  • the site of interest had at least 2 mm of keratinized gingiva on the facial aspect of the selected teeth

Exclusion criteria

  • Patients with abnormal platelet count
  • allergic to chlorhexidine or any other medicine used in the study
  • showing unacceptable oral hygiene compliance during / after the phase I therapy;
  • pregnant or lactating mothers;
  • smokers
  • endodontically involved teeth
  • patients under any medication known to interfere with periodontal healing. e.g., corticosteroids
  • on anticoagulant therapy
  • patients with transferable jobs or who were uncooperative
  • patients participating in other dental clinical trials.

Treatment and study plan

PRP combined with DFDBA

Other

Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA

DFDBA

Other

Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA

Primary outcomes

  1. Change in Probing Pocket Depth (PPD) from baseline to 12 months

    Time frame: baseline to 12 months

    PPD is vertical measurement from the free gingival margin to the base of the pocket measured to the nearest millimeter using a UNC (University of North Carolina) -15 periodontal probe.

  2. Change in Periodontal Attachment Level (PAL) from baseline to 12 months

    Time frame: baseline to 12 months

    PAL is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the base of the pocket measured to the nearest millimeter using UNC - 15 probe

  3. Change in Gingival Recession (GR) from baseline to 12 months

    Time frame: baseline to 12 months

    GR is vertical measurement recorded with the help of customized acrylic stent from a fixed reference point to the gingival margin measured to the nearest millimeter using UNC-15 probe

  4. Change in Crestal bone resorption from baseline to 12 months

    Time frame: baseline to 12 months

    Crestal bone resorption is the distance from Cementoenamel Junction to the Alveolar Crest (CEJ- AC); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest

  5. Change in Defect fill from baseline to 12 months

    Time frame: baseline to 12 months

    Defect fill is the distance from Cementoenamel Junction to Base of the Defect (CEJ- BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest

  6. Change in Defect resolution from baseline to 12 months

    Time frame: baseline to 12 months

    Defect resolution is the distance from the Alveolar Crest to Base of the Defect (AC - BD); measured in millimeters using standardized intraoral periapical (IOPA) radiographs along with a calibrated grid of the tooth of interest

Secondary outcomes

  1. Plaque Index

    Time frame: baseline to 12 months

    Silness and Loe, 1964

  2. Gingival Index

    Time frame: baseline to 12 months

    Loe and Silness, 1963

Sponsors and collaborators

Lead sponsor

Government Dental College and Hospital, India

Other Gov

Registry information

Official study title

Comparison of Efficacy of Autologous Platelet - Rich Plasma Combined With Demineralized Freeze - Dried Bone Allograft Versus Demineralized Freeze - Dried Bone Allograft: A Randomized Clinical Trial in Central India

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

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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