Effect of Concentrated Growth Factors on Short Implant-Supported Overdentures

NCT06880965 | Completed Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: R-OMPDR-8-23-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study will be to evaluate the effect of concentrated growth factors on stability and radiographic outcome of short implant supported mandibular assisted overdenture

Conditions

Partially Edentulous Patients

Keywords

CGF, Overdenture

Outcome Measures

Primary Outcomes (1)

• Concentrated growth factor (CGF) Effects

  evaluate the effects of concentrated growth factors on the stability of short implant-supported mandibular assisted partial overdentures. Periotest equipment was used to measure the stability of the implants in all of the patients immediately after surgery, six months later.

  one year

Study Arms (2)

short implants assisted over denture in combination with concentrated growth factors

ACTIVE COMPARATOR

the left side of the patients' mandibular posterior region was restored with short implant in place of first molar by using short implants assisted over denture with concentrated growth factor.

Diagnostic Test: testing implant stability; Drug: use concentrated growth factor.; Radiation: marginal bone loss calculation

using mandibular posterior short implants assisted over denture without concentrated growth factors

PLACEBO COMPARATOR

the right side of the patients' mandibular posterior region was restored with short implant in place of first molar by using short implants assisted over denture without concentrated growth factor.

Diagnostic Test: testing implant stability; Radiation: marginal bone loss calculation

Interventions

testing implant stability DIAGNOSTIC_TEST

testing implant stability by using the periotest device

short implants assisted over denture in combination with concentrated growth factors; using mandibular posterior short implants assisted over denture without concentrated growth factors

use concentrated growth factor. DRUG

short implants assisted over denture in combination with concentrated growth factor.

short implants assisted over denture in combination with concentrated growth factors

marginal bone loss calculation RADIATION

marginal bone loss calculation by digitized periapical radiograph

short implants assisted over denture in combination with concentrated growth factors; using mandibular posterior short implants assisted over denture without concentrated growth factors

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 20 to 65 years old. Class I Kennedy's classification Good oral hygiene.

You may not qualify if:

• Bad oral hygiene. Para functional habits ex. (bruxism, clenching,)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Gharbia Governorate, 31527, Egypt

Location

Study Officials

• Sherin F Donia, PHD

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at periodontology and oral medicine department Tanta university

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 18, 2025
• Study Start: August 24, 2023
• Primary Completion: November 25, 2024
• Study Completion: December 4, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 months after puplication
• Access Criteria: all the data

Locations

EG (1)