NCT02507596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

4.5 years

First QC Date

July 13, 2015

Last Update Submit

March 10, 2022

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • pocket depth

    Baseline and 6 months

  • bone defect area

    Baseline and 6 months

Study Arms (2)

Nano-crystalline hydroxyapatite silica gel

EXPERIMENTAL

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

Open flap debridement

SHAM COMPARATOR

an open periodontal flap without adding bone graft.

Procedure: open flap debridement

Interventions

Nano-crystalline hydroxyapatite silica gelBIOLOGICAL

it is a type of synthetic bone graft.

Also known as: Nanobone
Nano-crystalline hydroxyapatite silica gel
open flap debridementPROCEDURE

a periodontal surgical procedure for the purpose of debridement.

Also known as: OFD
Open flap debridement

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 14971256BACKGROUND

  • 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.

    PMID: 19680697BACKGROUND

  • 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.

    PMID: 18315420BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

NanoBone

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Weam Battawy, MD

    Lecturer of Oral Medicine and Periodontology

    STUDY CHAIR

  • Noha Ghallab, MD

    Associate Professor of Oral Medicine and Periodontology

    PRINCIPAL INVESTIGATOR

  • Dalia AbdelHamid, MD

    Associate Professor of Biomaterials

    STUDY DIRECTOR

  • Riham Hamdy, MD

    Associate Professor of Oral and Maxillofacial Radiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral Medicine and Periodontology

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 24, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

March 11, 2022

Record last verified: 2022-03

Locations

EG(1)