Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: open flap debridement; Procedure: n-HA bone graft

• Registration Number: NCT04643288
• Lead Sponsor: Weam Ahmed Elbattawy

Brief Summary

The present clinical trial included 20 patients (11 females and 9 males, aged 36 to 56 years) suffering from moderate or advanced chronic periodontitis. Subjects were recruited from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University. This clinical trial was meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with open flap debridement versus open flap debridement alone in the treatment of periodontal intrabony defects.

Detailed Description

periodontal intrabony defects in patients with moderate or advanced chronic periodontitis were treated with open flap debridement only in the control group while open flap debridement and Nanocrystalline Hydroxyapatite bone graft substitute was performed for the intervention group. probing pocket depth, clinical attachment level, gingival index, plaque index, gingival recession and bone defect area were assessed at baseline and six months post surgically to evaluate the possible improvement in the clinical and radiographic outcomes.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-11-25
• Study Completion: 2020-05-25
• Status Verified: 2020-11
• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-24
• Study First Posted: 2020-11-25
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• systemically healthy patients
• diagnosed with moderate to advanced chronic periodontitis
• periodontal defects with at least one site with probing pocket depth (PPD) ≥ 5mm, clinical attachment loss (CAL) ≥ 4mm and two or three-walled intra-bony defects ≥ 3mm
• evidence of intrabony defects using periapical radiographs

Exclusion Criteria

• teeth with suprabony defects or 1-wall intrabony defects
• pregnant or lactating women
• patients taking any medication 3 months prior to the study
• patients receiving any periodontal treatment 6 months prior to study initiation
• former or current smokers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n-HA bone graft intervention group	open flap debridement	Nanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects
OFD control group	open flap debridement	open flap debridement for periodontal intrabony defects
n-HA bone graft intervention group	n-HA bone graft	Nanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects

Primary Outcome Measures

Name	Time	Method
change in probing pocket depth	baseline and after six months	William's graduated periodontal probe used to measure probing pocket depth from the gingival margin to the base of the sulcus

Secondary Outcome Measures

Name	Time	Method
change in clinical attachment level	baseline and after six months	William's graduated periodontal probe used to measure clinical attachment level from the cementoenamel junction to the base of the sulcus
change in the bone defect area	baseline and after six months	periodical digital radiographs using Digora software to measure the bone defect area

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt