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

The Influence of Citric Acid Bone Surface Etching and Bone Substitute Intra-osseous Defect Fill on Crevicular Fluid BMP-2 Release Profile (Randomized Clinical Trial)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03769402
Enrollment
20
Registered
2018-12-07
Start date
2016-01-01
Completion date
2018-11-01
Last updated
2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrabony Periodontal Defect

Brief summary

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

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

Interventions

Citric acid ph1, 50% concentration solution

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bone Morphogenic protein 21 dayThe level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)

Secondary

MeasureTime frameDescription
Gingival Index6 monthsEstimation of the degree of gingival inflammation was done according to Loe where scores were given between 0-3 (0=no inflammation and 3=severe inflammation)
Plaque index6 monthsEstimation of the amount of dental plaque according to Silness & Loe where scores were given between 0-3 (0=no plaque and 3=presence of abundant plaque)
Probing depth6 monthsEstimation was done by measuring the depth from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe
Clinical attachment level6 monthsEstimation was done by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC-15 periodontal probe
Radiographic bone fill6 monthsEstimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026