Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

Chronic Periodontitis Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Open Flap Debridement With or Without Nanocrystalline Hydroxyapatite Bone Graft in Management of Periodontal Intrabony Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643288
• Other study ID #: nano version 1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: May 25, 2020

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 25, 2020
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 56 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• open flap debridement
open flap debridement for managing two and three walls intrabony periodontal defects
• n-HA bone graft
Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Weam Ahmed Elbattawy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in probing pocket depth	William's graduated periodontal probe used to measure probing pocket depth from the gingival margin to the base of the sulcus	baseline and after six months
Secondary	change in clinical attachment level	William's graduated periodontal probe used to measure clinical attachment level from the cementoenamel junction to the base of the sulcus	baseline and after six months
Secondary	change in the bone defect area	periodical digital radiographs using Digora software to measure the bone defect area	baseline and after six months