Clinical trial NCT03769402: The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrabony Periodontal Defect
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Bone Morphogenic protein 2
timeFrame: 1 day
measure: Bone Morphogenic protein 2
timeFrame: 3 days
measure: Bone Morphogenic protein 2
timeFrame: 7 days
measure: Bone Morphogenic protein 2
timeFrame: 14 days
measure: Bone Morphogenic protein 2
timeFrame: 30 days
Secondary outcomes:
measure: Gingival Index
timeFrame: 6 months
measure: Plaque index
timeFrame: 6 months
measure: Probing depth
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Radiographic bone fill
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
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