MedDataX Logo

The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile

NCT ID: NCT03769402

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the effect of citric acid on bone surface of infrabony defects when used for 30 seconds at ph 1 and 50% concentration before the application of bovine derived xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5 different days during the first month after surgery and clinical and radiographic parameters were reassessed after 6 months

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Citric acid have been widely used to treat root surfaces of periodontally affected teeth in order to render it biologically suitable for fibroblast reattachment. however, systematic reviews showed no clinical significance when it was used as a root surface conditioner. Recently it was found in experimental studies that when citric acid was used on bone surface for a brief period, it increased bone formation and improved consolidation of grafted bone to bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50% concentration for 30 seconds before washing it off and then application of bovine derived xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and radiographic parameters were taken after 6 months of follow-up

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intrabony Periodontal Defect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Citric acid

Citric acid PH1 and concentration 50% was used for 30 seconds on bone surface before washing it off and filling the defect with xenograft

Group Type ACTIVE_COMPARATOR

Citric acid

Intervention Type DRUG

Citric acid ph1, 50% concentration solution

Control

Control test

Group Type PLACEBO_COMPARATOR

Control Test

Intervention Type DRUG

Control group, xenograft was used to fill infrabony defects without treating bone surface

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Citric acid

Citric acid ph1, 50% concentration solution

Intervention Type DRUG

Control Test

Control group, xenograft was used to fill infrabony defects without treating bone surface

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Both genders aged between 32-60 years.
* Selected patient with a single site of:

1. Two walled or three walled infra-bony defect.
2. The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.
3. Pocket depth of more than or equal to 5 mm.
4. Clinical attachment loss equal or more than 3mm
* Patients ready to comply with oral hygiene measures.

Exclusion Criteria

* Any systemic disease that contra-indicates periodontal surgery or may affect healing.
* Smokers
* Pregnant females
* Drug abusers
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Moustafa Mukhtar

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

52-376

Identifier Type: -

Identifier Source: org_study_id