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NCT Number: NCT04643288

Nanocrystalline Hydroxyapatite Bone Substitute for Treating 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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11865, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Flap debridement

Procedure

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

n-HA bone graft

Procedure

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

Primary outcomes

  1. change in probing pocket depth

    Time frame: 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 outcomes

  1. change in clinical attachment level

    Time frame: 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

  2. change in the bone defect area

    Time frame: baseline and after six months

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

Sponsors and collaborators

Lead sponsor

Weam Ahmed Elbattawy

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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