Tooth ExtractionNCT07324083
Immediate Implant Loading After Ridge Preservation Using Autogenous Dentin Graft and Beta-Tricalcium Phosphate
A study testing Autogenous Mineralized Dentin Graft and Beta-Tricalcium Phosphate in people with Tooth Extraction and Alveolar Ridge Preservation, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aimed to evaluate the clinical, radiographic, and histological outcomes of immediate implant loading in extraction sockets preserved using autogenous mineralized dentin graft (AMDG), beta-tricalcium phosphate (β-TCP), or no grafting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tooth Extraction, Alveolar Ridge Preservation, Immediate Implant Loading
- What is being tested?
- Autogenous Mineralized Dentin Graft and Beta-Tricalcium Phosphate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Aug 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Patients requiring extraction of a maxillary premolar tooth
- Adequate bone height to allow delayed implant placement
- Good oral hygiene and compliance with follow-up visits
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Presence of uncontrolled systemic diseases that could affect bone healing
- History of radiotherapy to the head and neck region
- Heavy smoking
- Active infection or untreated periodontal disease at the extraction site
- History of bisphosphonate or other antiresorptive drug use
- Poor oral hygiene or inability to comply with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Implant Loading Following Ridge Preservation: A Randomized Controlled Trial Comparing Autogenous Mineralized Dentin Graft and Beta-Tricalcium Phosphate
This randomized controlled clinical trial aimed to evaluate the clinical, radiographic, and histological outcomes of immediate implant loading in extraction sockets preserved using autogenous mineralized dentin graft (AMDG), beta-tricalcium phosphate (β-TCP), or no grafting. Twenty-two patients requiring extraction of maxillary premolars were enrolled, contributing a total of 27 extraction sites. Sites were randomly allocated into three groups: AMDG, β-TCP, or ungrafted control.
Following socket preservation, dental implants were placed after a 6-month healing period and immediately loaded within 48 hours. Alveolar ridge dimensional changes were assessed using cone-beam computed tomography (CBCT) between implant placement and 2 years post-loading. Implant stability, peri-implant soft tissue health, and probing depths were evaluated at loading and during follow-up visits. Histological evaluation of regenerated bone was performed at the time of implant placement.
The study sought to determine whether AMDG provides comparable or superior outcomes to β-TCP and ungrafted sockets in supporting immediate implant loading.
Read the detailed description
Immediate implant loading requires adequate primary stability and sufficient bone volume and quality. Ridge preservation techniques are therefore critical in maintaining post-extraction socket dimensions. Autogenous dentin grafts have recently gained attention due to their osteoconductive properties, biocompatibility, and cost-effectiveness.
This study compares AMDG with a commonly used synthetic graft material (β-TCP) and ungrafted sockets to assess their influence on ridge preservation, implant stability, peri-implant tissue health, and bone quality under immediate loading conditions.
- Being tested
- Autogenous Mineralized Dentin Graft, Beta-Tricalcium Phosphate, Control (Ungrafted Socket)
- Keywords
- Socket preservation, immediate loading, autogenous dentin graft, beta-tricalcium phosphate, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous Mineralized Dentin GraftProcedure or surgery
Extraction sockets were preserved using AMDG prepared from the patient's own extracted tooth. Implants were placed 6 months post-grafting and immediately loaded within 48 hours.
Beta-Tricalcium PhosphateProcedure or surgery
Extraction sockets were preserved using synthetic β-TCP bone graft. Implants were placed 6 months post-grafting and immediately loaded within 48 hours.
Control (Ungrafted Socket)Procedure or surgery
Extraction sockets were left ungrafted and allowed to heal naturally. Implants were placed 6 months post-extraction and immediately loaded within 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous Mineralized Dentin Graft | Active comparator | Extraction sockets were preserved using AMDG prepared from the patient's own extracted tooth. Implants were placed 6 months post-grafting and immediately loaded within 48 hours. Receives: Procedure: Autogenous Mineralized Dentin Graft |
| Beta-Tricalcium Phosphate | Active comparator | Extraction sockets were preserved using synthetic β-TCP bone graft. Implants were placed 6 months post-grafting and immediately loaded within 48 hours. Receives: Procedure: Beta-Tricalcium Phosphate |
| Control (Ungrafted Socket) | Placebo comparator | Extraction sockets were left ungrafted and allowed to heal naturally. Implants were placed 6 months post-extraction and immediately loaded within 48 hours. Receives: Procedure: Control (Ungrafted Socket) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Ridge Width Change
Dimensional changes in alveolar ridge width were assessed using CBCT at the center, mesial, and distal sections of each implant site. Measurements were compared between the grafted (AMDG and β-TCP) and control groups over the follow-up period.Unit of Measure: Millimeters (mm)
Measured: From 6 months post-extraction (implant placement) to 2 years post-loading
Secondary outcomes (4)
Implant Stability Quotient (ISQ)
Implant stability was assessed using resonance frequency analysis to record ISQ values at each follow-up visit for all groups.Unit of Measure: ISQ units(0-100)
Measured: At implant loading, 3 months, and 6 months post-loading
Modified Sulcus Bleeding Index (mSBI)
Peri-implant soft tissue inflammation was evaluated using the mSBI at each follow-up visit for all groups. Unit of Measure: Index score (0-5 scale)
Measured: At implant loading, 3 months, and 6 months post-loading
Probing Pocket Depth (PPD)
Probing depth around each implant was measured using a periodontal probe to assess peri-implant tissue health across all groups.Unit of Measure: Millimeters (mm)
Measured: At implant loading, 3 months, and 6 months post-loading
Histological Bone Quality
Histological analysis of bone biopsies obtained from grafted and control sites was performed to evaluate bone maturity, remodeling, and osseointegration. Unit of Measure: Qualitative histological score.
Measured: 6 months post-grafting (at implant placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2023
- Primary completion1 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soaad Tolba Mohammed Tolba Badawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soaad Tolba Mohammed Tolba Badawi, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324083
- Sponsor's protocol ID
- R.25.12.95
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Loading Following Ridge Preservation: A Randomized Controlled Trial Comparing Autogenous Mineralized Dentin Graft and Beta-Tricalcium Phosphate
- ClinicalTrials.gov ID
- NCT07324083
- Acronym / sponsor ID
- R.25.12.95
- Keywords
- Socket preservation, immediate loading, autogenous dentin graft, beta-tricalcium phosphate, dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Soaad Tolba Mohammed Tolba BadawiUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 7 Jan 2026 (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 randomized controlled clinical trial aimed to evaluate the clinical, radiographic, and histological outcomes of immediate implant loading in extraction sockets preserved using autogenous mineralized dentin graft (AMDG), beta-tricalcium phosphate (β-TCP), or no grafting. Twenty-two patients requiring extraction of maxillary premolars were enrolled, contributing a total of 27 extraction sites. Sites were randomly allocated into three groups: AMDG, β-TCP, or ungrafted control.
Following socket preservation, dental implants were placed after a 6-month healing period and immediately loaded within 48 hours. Alveolar ridge dimensional changes were assessed using cone-beam computed tomography (CBCT) between implant placement and 2 years post-loading. Implant stability, peri-implant soft tissue health, and probing depths were evaluated at loading and during follow-up visits. Histological evaluation of regenerated bone was performed at the time of implant placement.
The study sought to determine whether AMDG provides comparable or superior outcomes to β-TCP and ungrafted sockets in supporting immediate implant loading.
Detailed description
Immediate implant loading requires adequate primary stability and sufficient bone volume and quality. Ridge preservation techniques are therefore critical in maintaining post-extraction socket dimensions. Autogenous dentin grafts have recently gained attention due to their osteoconductive properties, biocompatibility, and cost-effectiveness.
This study compares AMDG with a commonly used synthetic graft material (β-TCP) and ungrafted sockets to assess their influence on ridge preservation, implant stability, peri-implant tissue health, and bone quality under immediate loading conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autogenous Mineralized Dentin Graft | Active comparator | Procedure: Autogenous Mineralized Dentin GraftExtraction sockets were preserved using AMDG prepared from the patient's own extracted tooth. Implants were placed 6 months post-grafting and immediately loaded within 48 hours. |
| Beta-Tricalcium Phosphate | Active comparator | Procedure: Beta-Tricalcium PhosphateExtraction sockets were preserved using synthetic β-TCP bone graft. Implants were placed 6 months post-grafting and immediately loaded within 48 hours. |
| Control (Ungrafted Socket) | Placebo comparator | Procedure: Control (Ungrafted Socket)Extraction sockets were left ungrafted and allowed to heal naturally. Implants were placed 6 months post-extraction and immediately loaded within 48 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Patients requiring extraction of a maxillary premolar tooth
- Adequate bone height to allow delayed implant placement
- Good oral hygiene and compliance with follow-up visits
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (6 listed)
- Presence of uncontrolled systemic diseases that could affect bone healing
- History of radiotherapy to the head and neck region
- Heavy smoking
- Active infection or untreated periodontal disease at the extraction site
- History of bisphosphonate or other antiresorptive drug use
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 |
|---|---|---|
| Autogenous Mineralized Dentin GraftExtraction sockets were preserved using AMDG prepared from the patient's own extracted tooth. Implants were placed 6 months post-grafting and immediately loaded within 48 hours. | Procedure or surgery | Autogenous Mineralized Dentin Graft |
| Beta-Tricalcium PhosphateExtraction sockets were preserved using synthetic β-TCP bone graft. Implants were placed 6 months post-grafting and immediately loaded within 48 hours. | Procedure or surgery | Beta-Tricalcium Phosphate |
| Control (Ungrafted Socket)Extraction sockets were left ungrafted and allowed to heal naturally. Implants were placed 6 months post-extraction and immediately loaded within 48 hours. | Procedure or surgery | Control (Ungrafted Socket) |
Primary outcome
Alveolar Ridge Width Change
Time frame: From 6 months post-extraction (implant placement) to 2 years post-loading
Dimensional changes in alveolar ridge width were assessed using CBCT at the center, mesial, and distal sections of each implant site. Measurements were compared between the grafted (AMDG and β-TCP) and control groups over the follow-up period.Unit of Measure: Millimeters (mm)
4 secondary outcomes
Implant Stability Quotient (ISQ)
Time frame: At implant loading, 3 months, and 6 months post-loading
Modified Sulcus Bleeding Index (mSBI)
Time frame: At implant loading, 3 months, and 6 months post-loading
Probing Pocket Depth (PPD)
Time frame: At implant loading, 3 months, and 6 months post-loading
Histological Bone Quality
Time frame: 6 months post-grafting (at implant placement)
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous Mineralized Dentin Graft and Beta-Tricalcium Phosphate in people with Tooth Extraction and Alveolar Ridge Preservation, run by Soaad Tolba Mohammed Tolba Badawi 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 5 inclusion and 6 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 12 Jan 2026. 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.
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?
Alveolar Ridge Width Change (time frame: From 6 months post-extraction (implant placement) to 2 years post-loading). 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 12 Jan 2026.