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

NCT03769402 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 52-376
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Gingival Index

  6 months

• Plaque index

  6 months

• Probing depth

  6 months

• Clinical attachment level

  6 months

• Radiographic bone fill

  6 months

Study Arms (2)

Citric acid

ACTIVE COMPARATOR

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

Drug: Citric acid

Control

PLACEBO COMPARATOR

Control test

Drug: Control Test

Interventions

Citric acid DRUG

Citric acid ph1, 50% concentration solution

Citric acid

Control Test DRUG

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

Also known as: Control

Control

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders aged between 32-60 years.
• Selected patient with a single site of:
• Two walled or three walled infra-bony defect.
• The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.
• Pocket depth of more than or equal to 5 mm.
• Clinical attachment loss equal or more than 3mm
• Patients ready to comply with oral hygiene measures.

You may not qualify if:

• Any systemic disease that contra-indicates periodontal surgery or may affect healing.
• Smokers
• Pregnant females
• Drug abusers

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Citric Acid

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: January 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12