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

NCT04698317 | Completed Phase 2 DMC

• 1 other identifier: ≤ ≥ ° ± µ ™ ®
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Intrabony Periodontal Defect; Concentrated Growth Factors

Keywords

Beta-Tricalcium Phosphate; regeneration; concentrated growth factors

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

beta-tricalcium phosphate plus concentrated growth factors

EXPERIMENTAL

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

Procedure: open flap debridement; Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors

beta tricalcium phosphate alone(control group)

PLACEBO COMPARATOR

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

Procedure: open flap debridement; Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone

Interventions

open flap debridement PROCEDURE

Open flap for removal of diseased periodontal tissues and necrotic cementum

Also known as: periodontal surgery

beta tricalcium phosphate alone(control group); beta-tricalcium phosphate plus concentrated growth factors

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

Also known as: regenerative surgery

beta-tricalcium phosphate plus concentrated growth factors

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

Also known as: Regenerative surgery

beta tricalcium phosphate alone(control group)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Malak Mohamed Shoukheba

Tanta, 020, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

beta-tricalcium phosphate

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• malak m shoukheba

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate prof.

Model Details: 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).

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 6, 2021
• Study Start: January 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)