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

Sponsor

Government Dental College and Hospital, India (Other)

Overall Status

Completed

CT.gov ID

NCT05886699

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Other: PRP combined with DFDBA Other: DFDBA	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRP combined with DFDBA Open flap debridement, followed by placement of PRP combined with DFDBA	Other: PRP combined with DFDBA Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA
Active Comparator: DFDBA Open flap debridement, followed by placement of DFDBA	Other: DFDBA Periodontal intrabony defects were treated with open flap debridement followed by placement of PRP combined with DFDBA

Arm

Intervention/Treatment

Experimental: PRP combined with DFDBA

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

Other: PRP combined with DFDBA

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

Active Comparator: DFDBA

Open flap debridement, followed by placement of DFDBA

Other: DFDBA

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

Outcome Measures

Primary Outcome Measures

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
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 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 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 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

Secondary Outcome Measures

Plaque Index [baseline to 12 months]
Silness and Loe, 1964
Gingival Index [baseline to 12 months]
Loe and Silness, 1963

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	212, Department of Periodontology, Government Dental college and Hospital	Nagpur	Maharashtra	India	440003

Sponsors and Collaborators

Government Dental College and Hospital, India

Investigators

Principal Investigator: Pallavi A Meshram, MDS, Government Dental College and Hospital, Nagpur, India
Study Chair: Ramreddy K Yeltiwar, MDS, Rungta College of Dental Sciences and Research, Bhilai, India.
Study Director: Mangesh B Phadnaik, MDS, Government Dental College and Hospital, Nagpur, India