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Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nano-crystalline hydroxyapatite silica gel
open flap debridement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Severe chronic periodontitis patients.
  • having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

Exclusion Criteria:

  • Pregnant women
  • Subjects had <22 permanent teeth
  • Having any given systemic disease
  • Taking any type of medication and/or antibiotic therapy during the 3 months before the study
  • Received periodontal treatment within the past 12 months Current or former smokers

Sites / Locations

  • Faculty of Oral and Dental Medicine, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Nano-crystalline hydroxyapatite silica gel

Open flap debridement

Arm Description

hydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap

an open periodontal flap without adding bone graft.

Outcomes

Primary Outcome Measures

Clinical attachment level
Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month

Secondary Outcome Measures

pocket depth
Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months
bone defect area
Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month

Full Information

First Posted
July 13, 2015
Last Updated
March 10, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02507596
Brief Title
Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects
Official Title
Clinical and Radiographic Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in the Treatment of Human Periodontal Intrabony Defects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.
Detailed Description
Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Nano-crystalline hydroxyapatite silica gel
Arm Type
Experimental
Arm Description
hydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap
Arm Title
Open flap debridement
Arm Type
Sham Comparator
Arm Description
an open periodontal flap without adding bone graft.
Intervention Type
Biological
Intervention Name(s)
Nano-crystalline hydroxyapatite silica gel
Other Intervention Name(s)
Nanobone
Intervention Description
it is a type of synthetic bone graft.
Intervention Type
Procedure
Intervention Name(s)
open flap debridement
Other Intervention Name(s)
OFD
Intervention Description
a periodontal surgical procedure for the purpose of debridement.
Primary Outcome Measure Information:
Title
Clinical attachment level
Description
Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month
Time Frame
change from Baseline at 6 months
Secondary Outcome Measure Information:
Title
pocket depth
Description
Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months
Time Frame
Baseline and 6 months
Title
bone defect area
Description
Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Severe chronic periodontitis patients. having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs. Exclusion Criteria: Pregnant women Subjects had <22 permanent teeth Having any given systemic disease Taking any type of medication and/or antibiotic therapy during the 3 months before the study Received periodontal treatment within the past 12 months Current or former smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weam Battawy, MD
Organizational Affiliation
Lecturer of Oral Medicine and Periodontology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Noha Ghallab, MD
Organizational Affiliation
Associate Professor of Oral Medicine and Periodontology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dalia AbdelHamid, MD
Organizational Affiliation
Associate Professor of Biomaterials
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Riham Hamdy, MD
Organizational Affiliation
Associate Professor of Oral and Maxillofacial Radiology
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine, Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
14971256
Citation
Reynolds MA, Aichelmann-Reidy ME, Branch-Mays GL, Gunsolley JC. The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review. Ann Periodontol. 2003 Dec;8(1):227-65. doi: 10.1902/annals.2003.8.1.227.
Results Reference
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PubMed Identifier
19680697
Citation
Heinz B, Kasaj A, Teich M, Jepsen S. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study. Clin Oral Investig. 2010 Oct;14(5):525-31. doi: 10.1007/s00784-009-0325-x. Epub 2009 Aug 13.
Results Reference
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PubMed Identifier
18315420
Citation
Kasaj A, Rohrig B, Zafiropoulos GG, Willershausen B. Clinical evaluation of nanocrystalline hydroxyapatite paste in the treatment of human periodontal bony defects--a randomized controlled clinical trial: 6-month results. J Periodontol. 2008 Mar;79(3):394-400. doi: 10.1902/jop.2008.070378.
Results Reference
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Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects

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