Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: open flap debridement; Procedure: n-HA bone graft

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OFD control group; open flap debridement for periodontal intrabony defects	Procedure: open flap debridement; open flap debridement for managing two and three walls intrabony periodontal defects
Experimental: n-HA bone graft intervention group; Nanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects	Procedure: open flap debridement; open flap debridement for managing two and three walls intrabony periodontal defects; Procedure: n-HA bone graft; Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
change in the bone defect area	periodical digital radiographs using Digora software to measure the bone defect area	baseline and after six months

Collaborators and Investigators

• Sponsor: Weam Ahmed Elbattawy

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: periodontal intrabony defects
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: nano version 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No