Clinical trial NCT04698317: Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Intrabony Periodontal Defect
Concentrated Growth Factors
Keywords: Beta-Tricalcium Phosphate
regeneration
concentrated growth factors
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: gingival index
timeFrame: 6months
measure: bleeding on probing
timeFrame: 6 months
measure: probing pocket depth
timeFrame: 6 months
measure: clinical attachment level
timeFrame: 6 months
measure: cone beam x ray measuring defect area
timeFrame: 6 months
measure: cone beam x ray measuring bone density
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Malak Mohamed Shoukheba
Study officials:
affiliation: Cairo University
name: malak m shoukheba
role: PRINCIPAL_INVESTIGATOR
References: