Partially Edentulous PatientsPhase 2/3NCT06880965
Effect of Concentrated Growth Factors on Short Implant-Supported Overdentures
A Phase 2/3 study testing testing implant stability, use concentrated growth factor. and marginal bone loss calculation in people with Partially Edentulous Patients, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Partially Edentulous Patients
- What is being tested?
- testing implant stability, use concentrated growth factor. and marginal bone loss calculation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2023to 4 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 20 to 65 years old. Class I Kennedy's classification Good oral hygiene.
Who cannot join
- Bad oral hygiene. Para functional habits ex. (bruxism, clenching,)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Partially Edentulous Patients
- Being tested
- testing implant stability, use concentrated growth factor., marginal bone loss calculation
- Keywords
- CGF, Overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testing implant stabilityDiagnostic test
testing implant stability by using the periotest device
use concentrated growth factor.Drug
short implants assisted over denture in combination with concentrated growth factor.
marginal bone loss calculationRadiation
marginal bone loss calculation by digitized periapical radiograph
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: testing implant stability; Radiation: marginal bone loss calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start24 Aug 2023
- Primary completion25 Nov 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous PatientsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Atef, Tanta University
- Investigators
- Sherin F Donia, PHD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880965
- Sponsor's protocol ID
- R-OMPDR-8-23-2
- Status last verified
- Dec 2024
- First submitted
- 8 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concentrated Growth Factors on Short Implant-Supported Overdentures: a Split-Mouth Design Study.
- ClinicalTrials.gov ID
- NCT06880965
- Acronym / sponsor ID
- R-OMPDR-8-23-2
- Conditions
- Partially Edentulous Patients
- Keywords
- CGF, Overdenture
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short implants assisted over denture in combination with concentrated growth factors | Active comparator | Diagnostic Test: testing implant stability, Drug: use concentrated growth factor., Radiation: marginal bone loss calculationthe 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. |
| using mandibular posterior short implants assisted over denture without concentrated growth factors | Placebo comparator | Diagnostic Test: testing implant stability, Radiation: marginal bone loss calculationthe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 20 to 65 years old. Class I Kennedy's classification Good oral hygiene.
Key exclusion criteria (1 listed)
- Bad oral hygiene. Para functional habits ex. (bruxism, clenching,)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testing implant stabilitytesting implant stability by using the periotest device | Diagnostic test | 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.short implants assisted over denture in combination with concentrated growth factor. | Drug | short implants assisted over denture in combination with concentrated growth factors |
| marginal bone loss calculationmarginal bone loss calculation by digitized periapical radiograph | Radiation | short implants assisted over denture in combination with concentrated growth factors, using mandibular posterior short implants assisted over denture without concentrated growth factors |
Primary outcome
Concentrated growth factor (CGF) Effects
Time frame: one year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherin F Donia, PHD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing testing implant stability, use concentrated growth factor. and marginal bone loss calculation in people with Partially Edentulous Patients, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrated growth factor (CGF) Effects (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.