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

Phase 4

Completed

• Conditions: Intrabony Periodontal Defect
• Interventions: Drug: Control Test; Drug: Citric acid

• Registration Number: NCT03769402
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-11-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Last Update Submitted: 2018-12-06
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control Test	Control test
Citric acid	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

Primary Outcome Measures

Name	Time	Method
Bone Morphogenic protein 2	30 days	The 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 Outcome Measures

Name	Time	Method
Gingival Index	6 months	Estimation 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 index	6 months	Estimation 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 depth	6 months	Estimation 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 level	6 months	Estimation 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 fill	6 months	Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest