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Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
open flap debridement
n-HA bone graft
Sponsored by
Weam Ahmed Elbattawy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring periodontal intrabony defects

Eligibility Criteria

35 Years - 56 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

OFD control group

n-HA bone graft intervention group

Arm Description

open flap debridement for periodontal intrabony defects

Nanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
change in the bone defect area
periodical digital radiographs using Digora software to measure the bone defect area

Full Information

First Posted
November 14, 2020
Last Updated
November 24, 2020
Sponsor
Weam Ahmed Elbattawy
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1. Study Identification

Unique Protocol Identification Number
NCT04643288
Brief Title
Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects
Official Title
Clinical and Radiographic Evaluation of Open Flap Debridement With or Without Nanocrystalline Hydroxyapatite Bone Graft in Management of Periodontal Intrabony Defects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
May 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Weam Ahmed Elbattawy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
periodontal intrabony defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OFD control group
Arm Type
Experimental
Arm Description
open flap debridement for periodontal intrabony defects
Arm Title
n-HA bone graft intervention group
Arm Type
Experimental
Arm Description
Nanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects
Intervention Type
Procedure
Intervention Name(s)
open flap debridement
Intervention Description
open flap debridement for managing two and three walls intrabony periodontal defects
Intervention Type
Procedure
Intervention Name(s)
n-HA bone graft
Intervention Description
Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects
Primary Outcome Measure Information:
Title
change in probing pocket depth
Description
William's graduated periodontal probe used to measure probing pocket depth from the gingival margin to the base of the sulcus
Time Frame
baseline and after six months
Secondary Outcome Measure Information:
Title
change in clinical attachment level
Description
William's graduated periodontal probe used to measure clinical attachment level from the cementoenamel junction to the base of the sulcus
Time Frame
baseline and after six months
Title
change in the bone defect area
Description
periodical digital radiographs using Digora software to measure the bone defect area
Time Frame
baseline and after six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11865
Country
Egypt

12. IPD Sharing Statement

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Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

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