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

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ClinicalTrials.gov Identifier: NCT03769402
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Moustafa Mukhtar, 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

Condition or disease Intervention/treatment Phase
Intrabony Periodontal Defect Drug: Citric acid Drug: Control Test Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Citric acid
Citric acid ph1, 50% concentration solution

Placebo Comparator: Control
Control test
Drug: Control Test
Control group, xenograft was used to fill infrabony defects without treating bone surface
Other Name: Control




Primary Outcome Measures :
  1. Bone Morphogenic protein 2 [ Time Frame: 1 day ]
    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)

  2. Bone Morphogenic protein 2 [ Time Frame: 3 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)

  3. Bone Morphogenic protein 2 [ Time Frame: 7 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)

  4. Bone Morphogenic protein 2 [ Time Frame: 14 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)

  5. Bone Morphogenic protein 2 [ Time Frame: 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 :
  1. Gingival Index [ Time Frame: 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)

  2. Plaque index [ Time Frame: 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)

  3. Probing depth [ Time Frame: 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

  4. Clinical attachment level [ Time Frame: 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

  5. Radiographic bone fill [ Time Frame: 6 months ]
    Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Moustafa Mukhtar, Teaching assistant, Ain Shams University
ClinicalTrials.gov Identifier: NCT03769402     History of Changes
Other Study ID Numbers: 52-376
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Sodium Citrate
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action