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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05886699
• Other study ID #: PMeshram
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2023
• Source: Government Dental College and Hospital, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
India	212, Department of Periodontology, Government Dental college and Hospital	Nagpur	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Hospital, India

Country where clinical trial is conducted

India, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Plaque Index	Silness and Loe, 1964	baseline to 12 months
Secondary	Gingival Index	Loe and Silness, 1963	baseline to 12 months