Horizontal Ridge DeficiencyPhase 3MFNCT05418452
Efficacy of 1% Metformin Gel Mixed With PRF in Augmenting Narrow Ridge
A Phase 3 study testing Metformin in people with Horizontal Ridge Deficiency, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the efficacy of 1% metformin gel mixed with PRF, in horizontal ridge augmentation with the split-crest technique, for implant placement. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 15 Jun 2023
- Phase
- Phase 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults (age 18-50) exhibiting initial insufficiently bone ridge.
- Patients with good oral hygiene.
- Free from systemic diseases that may influence the outcome of the therapy.
Who cannot join
- Heavy smokers.
- Patient treated by immunosuppressive chemotherapy or radiotherapy,
- Allergy to any material or medication used in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AlAzhar universty
Cairo, 04444
abdalaziz k aboamo, +201068128254, abdel-azizabo-ammo.209@azhar.edu.eg
abdalaziz aboammo, +201068128254, abdel-azizabo-ammo.209@azhar.edu.eg
About this study
Official title: Efficacy of 1% Metformin Gel Mixed With PRF in Augmenting Narrow Ridge With Split-crest Technique and Implant Installation
This study aimed to evaluate the efficacy of 1% metformin gel mixed with PRF, in horizontal ridge augmentation with the split-crest technique, for implant placement.
Read the detailed description
Dental rehabilitation of edentulous patients with implants has become a common practice in the last few decades. Unfortunately, local conditions of some alveolar ridges of such patients may be challenging for implant placement. One of these conditions is a relevant horizontal deficit that may render dental implants difficult or impossible.
Several solutions are presented to overcome this challenge such as different guided bone regeneration (GBR) techniques and horizontal ridge split. However, these techniques have many shortages that may be overcome by the split crest technique (SCT).
SCT is a procedure for horizontal bone augmentation. It consists of splitting the vestibular and buccal cortical bone, displacing the vestibular cortical bone both in the maxilla or mandible, and separating from the bone marrow, creating a middle gap that is usually occupied mostly by the inserted implants. In such a procedure, ultrasonic bone surgery represents an advantageous alternative technique over conventional surgery using disks and chisels. The ultrasonic device can safely cut mineralized hard tissues such as bone with minor damage. Additionally, at the bone structural level, ultrasonic bone surgery may increase trabecular density as well as bone compression.
To enhance healing the remaining unoccupied space around the implant can be filled with biomaterials such as autologous bone grafts which are considered the gold stander, but unfortunately, site morbidity, as well as, utilizing more than one surgical site may limit its application. Alternatively, other bone substitutes including xenografts, alloplastic, and non-bone graft materials such as Platelet-Rich Fibrin (PRF) have been used in peri-implants space occupation.
PRF is a blood derivative in which platelets have a higher concentration above the baseline level. it can regulate inflammation and stimulate the immune process of chemotaxis. This natural material seems to accelerate the physiological wound healing with or without bone grafts to accelerate new bone formation. (6)In clinical practice, it has already been largely applied as an inexpensive carrier and way to obtain many growth factors (GFs) in physiological proportions. Hence, enhanced bone regeneration and favorable implant healing can be better achieved by using PRF as a graft around dental implants. Some authors reported that the use of PRF as a sole filling material during a simultaneous SCT and implantation stabilized a high volume of natural regenerated bone in the spaces unoccupied by the implants.
Lately, metformin (MF), an antidiabetic agent, has been successfully used as a local drug delivery agent in periodontitis patients. Literature has suggested that MF possesses the osteogenic potential and induces the growth of osteoblast precursor cells. Therefore, several human studies have reported the use of MF alone or combined with PRF in the treatment of bony defects Although PRF is an autogenous material obtained from a patient's blood and contains GFs which promote bone formation, its short time stability may not give it superiority over a commonly used bone graft like xenograft Adding a medical formula with osteogenic potential such as MF to PRF may add to its therapeutic performance and may present a graft material comparable to bone substitutes with the benefit of being cost-effective. Testing this hypothesis constitutes the primary aim of work in the present clinical study.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- Metformin
- Keywords
- implant, ridge split, metformin, PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
metformin (MF), an antidiabetic agent, has been successfully used as a local drug delivery agent in periodontitis patients. Literature has suggested that MF possesses the osteogenic potential and induces the growth of osteoblast precursor cells. Therefore, several human studies have reported the use of MF alone or combined with PRF in the treatment of bony defects
| Study group | Role | What they receive |
|---|---|---|
| metformin | Experimental | will receive split-crest technique by ultrasonic bone surgery with implant placement and PRF mixed with 1% metformin gel Receives: Drug: Metformin |
| control | No intervention | will receive split-crest technique by ultrasonic bone surgery with implant placement without gap filling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameter to measure difference
Implant stability (resonance frequency analysis)
Measured: to detect change from baseline at time (immediately after implant insertion) and after 6 months.
Secondary outcomes (1)
Radiological assessment to measure difference
bone height
Measured: to detect change from baseline (immediately after surgery), at time of loading (6 months), and 6 months after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start15 Jun 2022 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Ridge DeficiencyStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaziz Kamal Aboamo, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418452
- Sponsor's protocol ID
- 780/439
- Acronym
- MF
- Status last verified
- Jun 2022
- First submitted
- 28 Mar 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 1% Metformin Gel Mixed With PRF in Augmenting Narrow Ridge With Split-crest Technique and Implant Installation
- ClinicalTrials.gov ID
- NCT05418452
- Acronym / sponsor ID
- MF / 780/439
- Conditions
- Horizontal Ridge Deficiency
- Keywords
- implant, ridge split, metformin, PRF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 14 Jun 2022 (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.
This study aimed to evaluate the efficacy of 1% metformin gel mixed with PRF, in horizontal ridge augmentation with the split-crest technique, for implant placement.
Detailed description
Dental rehabilitation of edentulous patients with implants has become a common practice in the last few decades. Unfortunately, local conditions of some alveolar ridges of such patients may be challenging for implant placement. One of these conditions is a relevant horizontal deficit that may render dental implants difficult or impossible.
Several solutions are presented to overcome this challenge such as different guided bone regeneration (GBR) techniques and horizontal ridge split. However, these techniques have many shortages that may be overcome by the split crest technique (SCT).
SCT is a procedure for horizontal bone augmentation. It consists of splitting the vestibular and buccal cortical bone, displacing the vestibular cortical bone both in the maxilla or mandible, and separating from the bone marrow, creating a middle gap that is usually occupied mostly by the inserted implants. In such a procedure, ultrasonic bone surgery represents an advantageous alternative technique over conventional surgery using disks and chisels. The ultrasonic device can safely cut mineralized hard tissues such as bone with minor damage. Additionally, at the bone structural level, ultrasonic bone surgery may increase trabecular density as well as bone compression.
To enhance healing the remaining unoccupied space around the implant can be filled with biomaterials such as autologous bone grafts which are considered the gold stander, but unfortunately, site morbidity, as well as, utilizing more than one surgical site may limit its application. Alternatively, other bone substitutes including xenografts, alloplastic, and non-bone graft materials such as Platelet-Rich Fibrin (PRF) have been used in peri-implants space occupation.
PRF is a blood derivative in which platelets have a higher concentration above the baseline level. it can regulate inflammation and stimulate the immune process of chemotaxis. This natural material seems to accelerate the physiological wound healing with or without bone grafts to accelerate new bone formation. (6)In clinical practice, it has already been largely applied as an inexpensive carrier and way to obtain many growth factors (GFs) in physiological proportions. Hence, enhanced bone regeneration and favorable implant healing can be better achieved by using PRF as a graft around dental implants. Some authors reported that the use of PRF as a sole filling material during a simultaneous SCT and implantation stabilized a high volume of natural regenerated bone in the spaces unoccupied by the implants.
Lately, metformin (MF), an antidiabetic agent, has been successfully used as a local drug delivery agent in periodontitis patients. Literature has suggested that MF possesses the osteogenic potential and induces the growth of osteoblast precursor cells. Therefore, several human studies have reported the use of MF alone or combined with PRF in the treatment of bony defects Although PRF is an autogenous material obtained from a patient's blood and contains GFs which promote bone formation, its short time stability may not give it superiority over a commonly used bone graft like xenograft Adding a medical formula with osteogenic potential such as MF to PRF may add to its therapeutic performance and may present a graft material comparable to bone substitutes with the benefit of being cost-effective. Testing this hypothesis constitutes the primary aim of work in the present clinical study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin | Experimental | Drug: Metforminwill receive split-crest technique by ultrasonic bone surgery with implant placement and PRF mixed with 1% metformin gel |
| control | No intervention | –will receive split-crest technique by ultrasonic bone surgery with implant placement without gap filling. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults (age 18-50) exhibiting initial insufficiently bone ridge.
- Patients with good oral hygiene.
- Free from systemic diseases that may influence the outcome of the therapy.
Key exclusion criteria (3 listed)
- Heavy smokers.
- Patient treated by immunosuppressive chemotherapy or radiotherapy,
- Allergy to any material or medication used in the study.
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 |
|---|---|---|
| Metforminmetformin (MF), an antidiabetic agent, has been successfully used as a local drug delivery agent in periodontitis patients. Literature has suggested that MF possesses the osteogenic potential and induces the growth of osteoblast precursor cells. Therefore, several human studies have reported the use of MF alone or combined with PRF in the treatment of bony defects | Drug | metformin |
Primary outcome
Clinical parameter to measure difference
Time frame: to detect change from baseline at time (immediately after implant insertion) and after 6 months.
Implant stability (resonance frequency analysis)
1 secondary outcome
Radiological assessment to measure difference
Time frame: to detect change from baseline (immediately after surgery), at time of loading (6 months), and 6 months after loading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Horizontal Ridge Deficiency
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Alveolar Bone Loss, Alveolar Ridge Deficiency
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Horizontal Ridge Deficiency, run by Al-Azhar 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdalaziz k aboamo (+201068128254, abdel-azizabo-ammo.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical parameter to measure difference (time frame: to detect change from baseline at time (immediately after implant insertion) and after 6 months.). 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 14 Jun 2022.