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Completed

NCT Number: NCT03769402

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

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

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Key information

Conditions

Intrabony Periodontal Defect

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Citric acid

Drug

Citric acid ph1, 50% concentration solution

Control Test

Drug

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

Other names: Control

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2018
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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