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

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Other: PRP combined with DFDBA; Other: DFDBA

• Registration Number: NCT05886699
• Lead Sponsor: Government Dental College and Hospital, India

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Study First Submitted: 2015-03-02
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Defect resolution from baseline to 12 months	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
Change in Crestal bone resorption from baseline to 12 months	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
Change in Gingival Recession (GR) from baseline to 12 months	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
Change in Defect fill from baseline to 12 months	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
Change in Probing Pocket Depth (PPD) from baseline to 12 months	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.
Change in Periodontal Attachment Level (PAL) from baseline to 12 months	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

Secondary Outcome Measures

Name	Time	Method
Plaque Index	baseline to 12 months	Silness and Loe, 1964
Gingival Index	baseline to 12 months	Loe and Silness, 1963

Trial Locations

Locations (1)

212, Department of Periodontology, Government Dental college and Hospital; 🇮🇳 Nagpur, Maharashtra, India