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

NCT ID: NCT04698317

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-07-01

Brief Summary

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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

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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.

Conditions

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Chronic Periodontitis Intrabony Periodontal Defect Concentrated Growth Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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beta-tricalcium phosphate plus concentrated growth factors

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

Group Type EXPERIMENTAL

open flap debridement

Intervention Type PROCEDURE

Open flap for removal of diseased periodontal tissues and necrotic cementum

use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors

Intervention Type OTHER

use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect

beta tricalcium phosphate alone(control group)

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

Group Type PLACEBO_COMPARATOR

open flap debridement

Intervention Type PROCEDURE

Open flap for removal of diseased periodontal tissues and necrotic cementum

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

Intervention Type OTHER

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

Interventions

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open flap debridement

Open flap for removal of diseased periodontal tissues and necrotic cementum

Intervention Type PROCEDURE

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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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periodontal surgery regenerative surgery Regenerative surgery

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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malak mohamed shoukheba

associate prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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malak m shoukheba

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Malak Mohamed Shoukheba

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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≤ ≥ ° ± µ ™ ®

Identifier Type: -

Identifier Source: org_study_id

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