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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507596
• Other study ID #: Nanobone_IBD
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Biological:
• Nano-crystalline hydroxyapatite silica gel
it is a type of synthetic bone graft.

Procedure:
• open flap debridement
a periodontal surgical procedure for the purpose of debridement.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Kasaj A, Röhrig 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 . — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pocket depth	Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months	Baseline and 6 months
Secondary	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