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Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643288
Recruitment Status : Completed
First Posted : November 25, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Weam Ahmed Elbattawy, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: open flap debridement Procedure: n-HA bone graft Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Evaluation of Open Flap Debridement With or Without Nanocrystalline Hydroxyapatite Bone Graft in Management of Periodontal Intrabony Defects
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : November 25, 2019
Actual Study Completion Date : May 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
Drug Information available for: Durapatite

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643288


Locations
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Egypt
Cairo University
Cairo, Egypt, 11865
Sponsors and Collaborators
Weam Ahmed Elbattawy
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Weam Ahmed Elbattawy, Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04643288    
Other Study ID Numbers: nano version 1
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weam Ahmed Elbattawy, Cairo University:
periodontal intrabony defects
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases