Clincosm LogoSign in Get a demo

RCT: Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04698317
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
5.9
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.

Condition or Disease Intervention/Treatment Phase
  • Procedure: open flap debridement
  • Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors
  • Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
 Phase 2

Detailed Description

40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study. Each defect had intra-bony depth > or = 4 mm and probing pocket depth (PPD) > or = 6 mm. Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.

(control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).

Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
40 Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).40 Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Biodegradable Gelatin Sponge Loaded With Beta-Tricalcium Phosphate Sponges Incorporating Concentrated Growth Factors in the Treatment of Intra-bony Pocket Randomized Clinical and Radiographic Study
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: beta-tricalcium phosphate plus concentrated growth factors

surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).

Procedure: open flap debridement
Open flap for removal of diseased periodontal tissues and necrotic cementum
Other Names:
  • periodontal surgery

    • Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors
    use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect
    Other Names:
  • regenerative surgery

    		•
    Placebo Comparator: beta tricalcium phosphate alone(control group)

    surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group),

    Procedure: open flap debridement
    Open flap for removal of diseased periodontal tissues and necrotic cementum
    Other Names:
  • periodontal surgery

    • Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
    use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect
    Other Names:
  • Regenerative surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. gingival index [6months]

      gingival index will be recorded at baseline, 3, and 6 months at the site to be treated

    2. bleeding on probing [6 months]

      bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated

    3. probing pocket depth [6 months]

      probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated

    4. clinical attachment level [6 months]

      clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated

    5. cone beam x ray measuring defect area [6 months]

      defect area will be recorded at baseline, and 6 months at the site to be treated

    6. cone beam x ray measuring bone density [6 months]

      bone density will be recorded at baseline, and 6 months at the site to be treated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • systemically healthy patients were selected

    • patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.

    • Patients should demonstrate their ability to maintain good oral hygiene

    Exclusion Criteria:

    • Smokers and pregnant patients.

    • Medically compromised patients and systemic conditions precluding periodontal surgery.

    • Subjects who do not comply with oral hygiene measures as evidenced in recall visits.

    • Sites with tooth mobility

    • Restoration or caries in the site to be treated or non-vital tooth

    • Restoration or caries in the site to be treated or non-vital tooth

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Malak Mohamed Shoukheba Tanta Egypt 020

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: malak m shoukheba, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    malak mohamed shoukheba, associate prof., Tanta University
    ClinicalTrials.gov Identifier:
    NCT04698317
    Other Study ID Numbers:
    • ≤ ≥ ° ± µ ™ ®
    First Posted:
    Jan 6, 2021
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by malak mohamed shoukheba, associate prof., Tanta University
    Beta-Tricalcium Phosphate
    regeneration
    concentrated growth factors
    Additional relevant MeSH terms:
    Periodontitis
    Chronic Periodontitis
    Mitogens

    Study Results

    No Results Posted as of Oct 4, 2021