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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis; Intrabony Periodontal Defect; Concentrated Growth Factors
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 020
    • Malak Mohamed Shoukheba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival index	gingival index will be recorded at baseline, 3, and 6 months at the site to be treated	6months
bleeding on probing	bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
probing pocket depth	probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
clinical attachment level	clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
cone beam x ray measuring defect area	defect area will be recorded at baseline, and 6 months at the site to be treated	6 months
cone beam x ray measuring bone density	bone density will be recorded at baseline, and 6 months at the site to be treated	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: malak m shoukheba, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: regeneration; Beta-Tricalcium Phosphate; concentrated growth factors
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: ≤ ≥ ° ± µ ™ ®

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No