Effect of Concentrated Growth Factors on Short Implant-Supported Overdentures

Effect of Concentrated Growth Factors on Short Implant-Supported Overdentures: a Split-Mouth Design Study.

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

Study Overview

• Status: Completed
• Conditions: Partially Edentulous Patients
• Intervention / Treatment: Diagnostic test: testing implant stability; Drug: use concentrated growth factor.; Radiation: marginal bone loss calculation

Detailed Description

A controlled clinical trial will be performed upon patients attending the outpatient clinic of Faculty of Dentistry Tanta University.Ten male patients will be selected for this study. Split mouth study design will be used in this study where, Group I represented the right side of the patients' mandibular posterior region will be restored with short implant in place of first molar and Group II represented the left side of the patients' mandibular posterior region will be restored with short implant in place of first molar and concentrated growth factors. The patients will receive partial mandibular assisted overdenture with O-ring attachment on the implant. Stability of implant and Radiographic evaluations will be carried out for every patient at regular recall visits at the time of insertion, 6 and 12 months

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Gharbiya
    • Tanta, Gharbiya, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: short implants assisted over denture in combination with concentrated growth factors; 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; testing implant stability by using the periotest device; Drug: use concentrated growth factor.; short implants assisted over denture in combination with concentrated growth factor.; Radiation: marginal bone loss calculation; marginal bone loss calculation by digitized periapical radiograph
Placebo Comparator: using mandibular posterior short implants assisted over denture without concentrated growth factors; 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; testing implant stability by using the periotest device; Radiation: marginal bone loss calculation; marginal bone loss calculation by digitized periapical radiograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Sherin F Donia, PHD, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: CGF, Overdenture
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Mouth, Edentulous; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: R-OMPDR-8-23-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
• IPD Sharing Time Frame: 2 months after puplication
• IPD Sharing Access Criteria: all the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes