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

Intrabony Periodontal Defect Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769402
• Other study ID #: 52-376
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2016
• Est. completion date: November 1, 2018

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrabony Periodontal Defect

Intervention

Drug:
• Citric acid
Citric acid ph1, 50% concentration solution
• Control Test
Control group, xenograft was used to fill infrabony defects without treating bone surface

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Morphogenic protein 2	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)	1 day
Primary	Bone Morphogenic protein 2	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)	3 days
Primary	Bone Morphogenic protein 2	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)	7 days
Primary	Bone Morphogenic protein 2	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)	14 days
Primary	Bone Morphogenic protein 2	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)	30 days
Secondary	Gingival Index	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)	6 months
Secondary	Plaque index	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)	6 months
Secondary	Probing depth	Estimation was done by measuring the depth from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe	6 months
Secondary	Clinical attachment level	Estimation was done by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC-15 periodontal probe	6 months
Secondary	Radiographic bone fill	Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest	6 months