Tooth Loss in the Anterior MaxillaNCT07709676
Beta-Tricalcium Phosphate Grafting of Peri-implant Jumping Gaps Greater Than 2 mm in Immediate Implants
A study testing Experimental: Test: beta-tricalcium phosphate grafting in people with Tooth Loss in the Anterior Maxilla and Alveolar Bone Loss* / Therapy, run by Minia University at 1 site in Egypt.
Trial summary
This randomized controlled trial evaluated whether grafting the peri-implant "jumping gap" with injectable β-tricalcium phosphate (β-TCP) improves outcomes after immediate implant placement in sites where the horizontal gap between the implant surface and the surrounding socket wall exceeds 2 mm. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss in the Anterior Maxilla, Alveolar Bone Loss* / Therapy
- What is being tested?
- Experimental: Test: beta-tricalcium phosphate grafting
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Nov 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20 to 50 years
- Non-restorable maxillary anterior or premolar tooth requiring extraction and immediate implant placement
- Peri-implant jumping gap greater than 2 mm at the implant site
- Adequate inter-arch space
- Good patient compliance
Who cannot join
- • Systemic disease affecting healing
- Smoking of more than 10 cigarettes per day
- Parafunctional habits
- Poor oral hygiene
- Active periodontal disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
Ismailia
About this study
Official title: Effect of Beta-Tricalcium Phosphate (β-TCP) Grafting on Implant Stability and Peri-implant Bone Density Following Immediate Implant Placement in Sites With Jumping Gaps Exceeding 2 mm: A Randomized Controlled Trial
This randomized controlled trial evaluated whether grafting the peri-implant "jumping gap" with injectable β-tricalcium phosphate (β-TCP) improves outcomes after immediate implant placement in sites where the horizontal gap between the implant surface and the surrounding socket wall exceeds 2 mm. Sixteen patients (a total of 39 immediate implants in the maxillary anterior and premolar regions) were randomly allocated in a 1:1 ratio to a test group (peri-implant gap filled with injectable β-TCP) or a control group (no grafting). The patient was the unit of analysis. The primary outcome was implant stability, measured by resonance frequency analysis and expressed as the implant stability quotient (ISQ) at baseline, 3 months, and 6 months. The secondary outcome was peri-implant bone density, monitored on standardized digital periapical radiographs (baseline, 3, and 6 months) and quantified at 6 months by a single cone-beam computed tomography (CBCT) scan.
Read the detailed description
Design: single-center, prospective, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Suez Canal University (approval no. 682/2023), and all procedures were performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Participants: patients aged 20-50 years requiring extraction of a non-restorable maxillary anterior or premolar root, with a peri-implant jumping gap greater than 2 mm at the implant site.
Interventions: after atraumatic extraction and prosthetically driven osteotomy preparation, implants were placed at the crestal level. In the test group the peri-implant gap was filled with injectable β-TCP; in the control group no grafting was performed.
Randomization and blinding: the allocation sequence was computer-generated by an investigator not involved in surgery, with concealment by sequentially numbered, opaque, sealed envelopes. Outcome assessors, including the radiographic bone-density readers, were blinded to group allocation.
Outcomes: the primary outcome was implant stability (ISQ) at baseline, 3, and 6 months. Secondary outcomes were peri-implant bone density on periapical radiographs (Digora grayscale, 0-255) and on a single 6-month CBCT (gray-value-derived HU-equivalent radiodensity), and implant survival. Analysis used independent-samples t tests for between-group and repeated-measures ANOVA for within-group comparisons (α = 0.05), with the patient as the unit of analysis.
- Being tested
- Experimental: Test: beta-tricalcium phosphate grafting
- Keywords
- Immediate dental implant, Beta-tricalcium phosphate, Bone graft, Osseointegration, Implant stability
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Test: beta-tricalcium phosphate graftingDevice
A β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th
| Study group | Role | What they receive |
|---|---|---|
| control; no grafting | No intervention | Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with no grafting of the peri-implant gap. |
| Test: beta-tricalcium phosphate grafting | Experimental | Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with the gap filled with injectable β-tricalcium phosphate (β-TCP) after implant placement. Receives: Device: Experimental: Test: beta-tricalcium phosphate grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability (implant stability quotient, ISQ)
Implant stability measured by resonance frequency analysis and expressed as the ISQ (unitless, 1-100; higher = more stable). The patient was the unit of analysis; for patients with more than one implant, the mean ISQ of that patient's implants was used.
Measured: Baseline (immediately postoperative), 3 months, and 6 months
Secondary outcomes (3)
Peri-implant bone density on periapical radiographs (Digora grayscale)
Bone density on standardized digital periapical radiographs (paralleling technique, fixed exposure), analyzed with Digora software as grayscale values (0-255) at the mesial, distal, and apical regions.
Measured: Baseline, 3 months, and 6 months
Peri-implant radiodensity on 6-month cone-beam CT (HU-equivalent)
Radiodensity on a single 6-month CBCT along the buccal aspect of each implant at apical, middle, and crestal levels, expressed as gray-value-derived HU-equivalent values; read independently by two blinded radiologists.
Measured: 6 month
Implant survival
Proportion of implants surviving to the 6-month follow-up, with assessment of infection, implant mobility, and wound dehiscence at each visit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Dec 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
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 Tooth Loss in the Anterior MaxillaStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Hassan, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709676
- Sponsor's protocol ID
- 682/2023
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salem AA, Hammed MS, ElRawdy AM, ElHawary H. Effect of beta-tricalcium phosphate grafting on implant stability and peri-implant radiodensity following immediate implant placement in sites with jumping gaps exceeding 2 mm: a randomized controlled trial. BMC Oral Health. 2026 Sep 21;26(1):1780. doi: 10.1186/s12903-026-09810-5.
PubMed 42768341
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beta-Tricalcium Phosphate (β-TCP) Grafting on Implant Stability and Peri-implant Bone Density Following Immediate Implant Placement in Sites With Jumping Gaps Exceeding 2 mm: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07709676
- Acronym / sponsor ID
- 682/2023
- Keywords
- Immediate dental implant, Beta-tricalcium phosphate, Bone graft, Osseointegration, Implant stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 16 Jul 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 trial evaluated whether grafting the peri-implant "jumping gap" with injectable β-tricalcium phosphate (β-TCP) improves outcomes after immediate implant placement in sites where the horizontal gap between the implant surface and the surrounding socket wall exceeds 2 mm. Sixteen patients (a total of 39 immediate implants in the maxillary anterior and premolar regions) were randomly allocated in a 1:1 ratio to a test group (peri-implant gap filled with injectable β-TCP) or a control group (no grafting). The patient was the unit of analysis. The primary outcome was implant stability, measured by resonance frequency analysis and expressed as the implant stability quotient (ISQ) at baseline, 3 months, and 6 months. The secondary outcome was peri-implant bone density, monitored on standardized digital periapical radiographs (baseline, 3, and 6 months) and quantified at 6 months by a single cone-beam computed tomography (CBCT) scan.
Detailed description
Design: single-center, prospective, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Suez Canal University (approval no. 682/2023), and all procedures were performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Participants: patients aged 20-50 years requiring extraction of a non-restorable maxillary anterior or premolar root, with a peri-implant jumping gap greater than 2 mm at the implant site.
Interventions: after atraumatic extraction and prosthetically driven osteotomy preparation, implants were placed at the crestal level. In the test group the peri-implant gap was filled with injectable β-TCP; in the control group no grafting was performed.
Randomization and blinding: the allocation sequence was computer-generated by an investigator not involved in surgery, with concealment by sequentially numbered, opaque, sealed envelopes. Outcome assessors, including the radiographic bone-density readers, were blinded to group allocation.
Outcomes: the primary outcome was implant stability (ISQ) at baseline, 3, and 6 months. Secondary outcomes were peri-implant bone density on periapical radiographs (Digora grayscale, 0-255) and on a single 6-month CBCT (gray-value-derived HU-equivalent radiodensity), and implant survival. Analysis used independent-samples t tests for between-group and repeated-measures ANOVA for within-group comparisons (α = 0.05), with the patient as the unit of analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control; no grafting | No intervention | –Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with no grafting of the peri-implant gap. |
| Test: beta-tricalcium phosphate grafting | Experimental | Device: Experimental: Test: beta-tricalcium phosphate graftingImmediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with the gap filled with injectable β-tricalcium phosphate (β-TCP) after implant placement. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20 to 50 years
- Non-restorable maxillary anterior or premolar tooth requiring extraction and immediate implant placement
- Peri-implant jumping gap greater than 2 mm at the implant site
- Adequate inter-arch space
- Good patient compliance
Key exclusion criteria (5 listed)
- • Systemic disease affecting healing
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 |
|---|---|---|
| Experimental: Test: beta-tricalcium phosphate graftingA β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th | Device | Test: beta-tricalcium phosphate grafting |
Primary outcome
Implant stability (implant stability quotient, ISQ)
Time frame: Baseline (immediately postoperative), 3 months, and 6 months
Implant stability measured by resonance frequency analysis and expressed as the ISQ (unitless, 1-100; higher = more stable). The patient was the unit of analysis; for patients with more than one implant, the mean ISQ of that patient's implants was used.
3 secondary outcomes
Peri-implant bone density on periapical radiographs (Digora grayscale)
Time frame: Baseline, 3 months, and 6 months
Peri-implant radiodensity on 6-month cone-beam CT (HU-equivalent)
Time frame: 6 month
Implant survival
Time frame: 6 months
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 16 Jul 2026.
- Derived from this study: PubMed 42768341Salem AA, Hammed MS, ElRawdy AM, ElHawary H. Effect of beta-tricalcium phosphate grafting on implant stability and peri-implant radiodensity following immediate implant placement in sites with jumping gaps exceeding 2 mm: a randomized controlled trial. BMC Oral Health. 2026 Sep 21;26(1):1780. doi: 10.1186/s12903-026-09810-5.
- 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. 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 Experimental: Test: beta-tricalcium phosphate grafting in people with Tooth Loss in the Anterior Maxilla and Alveolar Bone Loss* / Therapy, run by Minia 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 5 inclusion and 5 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 16 Jul 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. 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?
Implant stability (implant stability quotient, ISQ) (time frame: Baseline (immediately postoperative), 3 months, and 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 NCT07709676, 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 16 Jul 2026.