NCT04643288

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

November 14, 2020

Last Update Submit

November 24, 2020

Conditions

Chronic Periodontitis

Keywords

periodontal intrabony defects

Outcome Measures

Primary Outcomes (1)

  • change in probing pocket depth

    William's graduated periodontal probe used to measure probing pocket depth from the gingival margin to the base of the sulcus

    baseline and after six months

Secondary Outcomes (2)

  • change in clinical attachment level

    baseline and after six months

  • change in the bone defect area

    baseline and after six months

Study Arms (2)

OFD control group

EXPERIMENTAL

open flap debridement for periodontal intrabony defects

Procedure: open flap debridement

n-HA bone graft intervention group

EXPERIMENTAL

Nanocrystalline Hydroxyapatite (n-HA) bone graft substitute was added to periodontal intrabony defects

Procedure: open flap debridementProcedure: n-HA bone graft

Interventions

open flap debridementPROCEDURE

open flap debridement for managing two and three walls intrabony periodontal defects

OFD control groupn-HA bone graft intervention group
n-HA bone graftPROCEDURE

Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects

n-HA bone graft intervention group

Eligibility Criteria

Age35 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 14, 2020

First Posted

November 25, 2020

Study Start

September 1, 2018

Primary Completion

November 25, 2019

Study Completion

May 25, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Locations

EG(1)