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

NCT05886699 | Completed DMC

• 1 other identifier: PMeshram
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Periodontitis

Keywords

platelet - rich plasma; demineralized freeze - dried bone allograft; intrabony defect; periodontitis.

Outcome Measures

Primary Outcomes (6)

• Change in Probing Pocket Depth (PPD) from 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.

  baseline to 12 months

• Change in Periodontal Attachment Level (PAL) from 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

  baseline to 12 months

• Change in Gingival Recession (GR) from 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

  baseline to 12 months

• Change in Crestal bone resorption from 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

  baseline to 12 months

• Change in Defect fill from 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

  baseline to 12 months

• Change in Defect resolution from 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

  baseline to 12 months

Secondary Outcomes (2)

• Plaque Index

  baseline to 12 months

• Gingival Index

  baseline to 12 months

Study Arms (2)

PRP combined with DFDBA

EXPERIMENTAL

Open flap debridement, followed by placement of PRP combined with DFDBA

Other: PRP combined with DFDBA

DFDBA

ACTIVE COMPARATOR

Open flap debridement, followed by placement of DFDBA

Other: DFDBA

Interventions

PRP combined with DFDBA OTHER

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

PRP combined with DFDBA

DFDBA OTHER

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

DFDBA

Eligibility Criteria

• Age: 28 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Hospital, India: lead

Study Sites (1)

212, Department of Periodontology, Government Dental college and Hospital

Nagpur, Maharashtra, 440003, India

Location

Related Publications (38)

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MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Pallavi A Meshram, MDS

  Government Dental College and Hospital, Nagpur, India

  PRINCIPAL INVESTIGATOR

• Ramreddy K Yeltiwar, MDS

  Rungta College of Dental Sciences and Research, Bhilai, India.

  STUDY CHAIR

• Mangesh B Phadnaik, MDS

  Government Dental College and Hospital, Nagpur, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: June 2, 2023
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: to other researchers

Locations

IN (1)