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NCT Number: NCT04698317

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

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Concentrated Growth Factors Disease Attributes Intrabony Periodontal Defect Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Malak Mohamed Shoukheba

Tanta, 020, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Open Flap debridement

Procedure

Open flap for removal of diseased periodontal tissues and necrotic cementum

Other names: periodontal surgery

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 incorporating Concentrated Growth Factors in Periodontal Defect

Other names: regenerative surgery

use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone

Other

use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect

Other names: Regenerative surgery

Primary outcomes

  1. gingival index

    Time frame: 6months

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

  2. bleeding on probing

    Time frame: 6 months

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

  3. probing pocket depth

    Time frame: 6 months

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

  4. clinical attachment level

    Time frame: 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

    Time frame: 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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Oct 4, 2021

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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