Dimensional Changes After Tooth ExtractionNCT07086859
Alveolar Ridge Preservation Using Autogenous Whole Tooth Graft With 1 %Metformin :A Randomized Controlled Clinical Trial
A study testing TEST 1 in people with Dimensional Changes After Tooth Extraction and Tooth Extraaction, run by Cairo University at 1 site in Egypt.
Trial summary
This study describes a technique used to preserve the bone dimensions after the tooth extraction inorder to facilitate later on the dental implant placement Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dimensional Changes After Tooth Extraction, Tooth Extraaction, Socket Preservation
- What is being tested?
- TEST 1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- patients requiring single extraction of non-molar tooth
- extraction sockets having more than 50% buccal alveolar bone loss
Who cannot join
- Pregnancy
- smokers
- patients not maintaing good oral hygiene
- presernce of acute endodontic infection in the tooth to be ectracted
- medical conditions hindering implant placement
- uncontrolled diabetes
- Immune suppression
- bisphosphanates
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study describes a technique used to preserve the bone dimensions after the tooth extraction inorder to facilitate later on the dental implant placement
Read the detailed description
Socket preservation by type of graft used from the tooth combined with Metformin to enhace the results of the bone formation
- Being tested
- TEST 1, Control
- Keywords
- Alveolar ridge preservation, socket preservation, Autogenous Whole tooth Graft, AWTG, Tooth grafting, tooth extraction, bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEST 1Procedure or surgery
Autogenous whole tooth graft with metformin
ControlProcedure or surgery
Autogenous whole tooth graft
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Autogenous Whole tooth graft + Metformin in the socket of extracted non-molar tooth Receives: Procedure: TEST 1 |
| Control | Active comparator | Autogenous whole tooth graft Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic buccolingual width ridge loss
Measuring the CBCT these dimensions pre operative and after 6 months
Measured: 6 months
Secondary outcomes (5)
Alveolar buccal ridge height, lingual ridge height
Measuring them on CBCT pre operative and after 6 months
Measured: 6 months
the area percentage of newly formed bone, soft tissue and residual graft
By Histology after taking a biopsy after 6 months
Measured: 6 months
Patient satisfaction evaluation
by visual analog scale (0-10)
Measured: 2 weeks
Total number of analgesics taken in the first week
by asking the patient
Measured: 1 week
Socket wound healing score
by taking occlusal clinical pictures of socket
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dimensional Changes After Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mohamed Hassan Gadallah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086859
- Sponsor's protocol ID
- 279
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elfana A, El-Kholy S, Saleh HA, Fawzy El-Sayed K. Alveolar ridge preservation using autogenous whole-tooth versus demineralized dentin grafts: A randomized controlled clinical trial. Clin Oral Implants Res. 2021 May;32(5):539-548. doi: 10.1111/clr.13722. Epub 2021 Mar 1.
PubMed 33565656
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation Using Autogenous Whole Tooth Graft With 1 %Metformin :A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07086859
- Acronym / sponsor ID
- 279
- Keywords
- Alveolar ridge preservation, socket preservation, Autogenous Whole tooth Graft, AWTG, Tooth grafting, tooth extraction, bone graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 25 Jul 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.
This study describes a technique used to preserve the bone dimensions after the tooth extraction inorder to facilitate later on the dental implant placement
Detailed description
Socket preservation by type of graft used from the tooth combined with Metformin to enhace the results of the bone formation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Procedure: TEST 1Autogenous Whole tooth graft + Metformin in the socket of extracted non-molar tooth |
| Control | Active comparator | Procedure: ControlAutogenous whole tooth graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- patients requiring single extraction of non-molar tooth
- extraction sockets having more than 50% buccal alveolar bone loss
Key exclusion criteria (8 listed)
- Pregnancy
- smokers
- patients not maintaing good oral hygiene
- presernce of acute endodontic infection in the tooth to be ectracted
- medical conditions hindering implant placement
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 |
|---|---|---|
| TEST 1Autogenous whole tooth graft with metformin | Procedure or surgery | Test |
| ControlAutogenous whole tooth graft | Procedure or surgery | Control |
Primary outcome
Radiographic buccolingual width ridge loss
Time frame: 6 months
Measuring the CBCT these dimensions pre operative and after 6 months
5 secondary outcomes
Alveolar buccal ridge height, lingual ridge height
Time frame: 6 months
the area percentage of newly formed bone, soft tissue and residual graft
Time frame: 6 months
Patient satisfaction evaluation
Time frame: 2 weeks
Total number of analgesics taken in the first week
Time frame: 1 week
Socket wound healing score
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 33565656Elfana A, El-Kholy S, Saleh HA, Fawzy El-Sayed K. Alveolar ridge preservation using autogenous whole-tooth versus demineralized dentin grafts: A randomized controlled clinical trial. Clin Oral Implants Res. 2021 May;32(5):539-548. doi: 10.1111/clr.13722. Epub 2021 Mar 1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEST 1 in people with Dimensional Changes After Tooth Extraction and Tooth Extraaction, run by Cairo 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 8 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: opening soon, as of the sponsor's last update on 25 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada Gadallah, Masters Degree Candidate (+201000130279, nada.gadallah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic buccolingual width ridge loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07086859, which also lists 1 linked publication.
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 25 Jul 2025.