MedDataX Logo

Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

NCT ID: NCT04643288

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

periodontal intrabony defects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OFD control group

open flap debridement for periodontal intrabony defects

Group Type EXPERIMENTAL

open flap debridement

Intervention Type PROCEDURE

open flap debridement for managing two and three walls intrabony periodontal defects

n-HA bone graft intervention group

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

Group Type EXPERIMENTAL

open flap debridement

Intervention Type PROCEDURE

open flap debridement for managing two and three walls intrabony periodontal defects

n-HA bone graft

Intervention Type PROCEDURE

Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

open flap debridement

open flap debridement for managing two and three walls intrabony periodontal defects

Intervention Type PROCEDURE

n-HA bone graft

Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Weam Ahmed Elbattawy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Weam Ahmed Elbattawy

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

nano version 1

Identifier Type: -

Identifier Source: org_study_id