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

Clinical and Radiographic Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in the Treatment of Human Periodontal Intrabony Defects

A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Biological: Nano-crystalline hydroxyapatite silica gel; Procedure: open flap debridement

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of oral and dental medicine, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano-crystalline hydroxyapatite silica gel; hydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap	Biological: Nano-crystalline hydroxyapatite silica gel; it is a type of synthetic bone graft.; Other Names: Nanobone
Sham Comparator: Open flap debridement; an open periodontal flap without adding bone graft.	Procedure: open flap debridement; a periodontal surgical procedure for the purpose of debridement.; Other Names: OFD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month	change from Baseline at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pocket depth	Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months	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	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Weam Battawy, MD, Lecturer of Oral Medicine and Periodontology; Principal Investigator: Noha Ghallab, MD, Associate Professor of Oral Medicine and Periodontology; Study Director: Dalia AbdelHamid, MD, Associate Professor of Biomaterials; Study Chair: Riham Hamdy, MD, Associate Professor of Oral and Maxillofacial Radiology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: Nanobone_IBD