Dental ImplantNCT06416605
Autogenous Tooth Graft for Ridge Augmentation
A study testing Maxillary Alveolar Ridge Augmentation in people with Dental Implant, run by Mansoura University at 1 site in Egypt.
Trial summary
This study is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Maxillary Alveolar Ridge Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Dec 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- One or two maxillary extracted teeth with crestal bone width of 4 mm or less.
- 2- Age ranging from 1850 years 3- 3- Adequate oral hygiene. 4- Non smoking patients. 5-Free from any pathological lesions related to the tooth to be extracted. 6- Physically fit to withstand the whole procedure.
Who cannot join
- 1- Active infection in the site to be treated. 2- Patients on chemotherapy or radiotherapy. 3- Alcohol or drug abuse. 4- Patients who have systemic disorders that interfere with bone healing {uncontrolled diabetes mellitus, autoimmune disease,
- etc.} 5- Pregnancy. 6- Patients with bone disease. 7- Patients with parafunctional habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tooth Shell Versus Bone Shell Technique For Horizontal Maxillary Alveolar Ridge Augmentation
This study is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft.
Read the detailed description
twenty eight patients with one or two maxillary extracted teeth in need for horizontal bone augmentation and implant placement will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University patients will be divided into two equal groups:
- Group I: Horizontal bone augmentation will be done by bone shell technique.
- Group II: Horizontal bone augmentation will be done by autogenous tooth shell technique.
Evaluation:
A-Clinical evaluation:
- All patients were followed up on a weekly basis for the first postoperative month, then monthly for the rest of the postoperative period (6months) until implantation.
- The patients were evaluated regarding pain, edema and hematoma at recipient and donor sites as well as healing of the mucosa.
- A neurosensory evaluation was carried out at each clinical check up by asking the patient if there were any areas of hypoesthesia, numbness or tingling in the lower lip and chin at the side of the donor site.
B-Radiographic evaluation
•Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement. According to the measurements obtained from CBCT, appropriate implant size and length will be chosen and placed 6 months postoperative after removal of the micro screws.
Radiographic analysis:
Linear measurements of alveolar bone width were taken using CBCT scan at three stages; prior to grafting (T0) and immediately (T1), and 4 months post grafting (T2). Then three horizontal alveolar width measurements (crestal, middle and apical) were recorded at T0, T2 and T1. The measurement was performed with fixed points each time, the buccolingual width was measured at different levels. At the bone crest, 3mm from the bone crest and 6mm from the bone crest. The measurements were tabulated for statistical analysis.
- Conditions
- Dental Implant
- Being tested
- Maxillary Alveolar Ridge Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary Alveolar Ridge AugmentationProcedure or surgery
using tooth graft or bone graft to increase alveolar ridge width to be able to insert dental implant
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Horizontal bone augmentation will be done by bone shell technique Receives: Procedure: Maxillary Alveolar Ridge Augmentation |
| group B | Experimental | Horizontal bone augmentation will be done by autogenous tooth shell technique Receives: Procedure: Maxillary Alveolar Ridge Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
horizontal alveolar width measurements
Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement.
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 May 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion30 Dec 2024 (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 Dental ImplantStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Elsheikh, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416605
- Sponsor's protocol ID
- A03030123
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Awad KAI, Tawik MA, Hussein MM, El-Farag SAA, Sameaa SESA. Tooth shell versus bone shell technique for horizontal maxillary alveolar ridge augmentation. BMC Oral Health. 2025 Apr 25;25(1):642. doi: 10.1186/s12903-025-05940-4.
PubMed 40281533
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Shell Versus Bone Shell Technique For Horizontal Maxillary Alveolar Ridge Augmentation
- ClinicalTrials.gov ID
- NCT06416605
- Acronym / sponsor ID
- A03030123
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 May 2024 (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 is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft.
Detailed description
twenty eight patients with one or two maxillary extracted teeth in need for horizontal bone augmentation and implant placement will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University patients will be divided into two equal groups:
- Group I: Horizontal bone augmentation will be done by bone shell technique.
- Group II: Horizontal bone augmentation will be done by autogenous tooth shell technique.
Evaluation:
A-Clinical evaluation:
- All patients were followed up on a weekly basis for the first postoperative month, then monthly for the rest of the postoperative period (6months) until implantation.
- The patients were evaluated regarding pain, edema and hematoma at recipient and donor sites as well as healing of the mucosa.
- A neurosensory evaluation was carried out at each clinical check up by asking the patient if there were any areas of hypoesthesia, numbness or tingling in the lower lip and chin at the side of the donor site.
B-Radiographic evaluation
•Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement. According to the measurements obtained from CBCT, appropriate implant size and length will be chosen and placed 6 months postoperative after removal of the micro screws.
Radiographic analysis:
Linear measurements of alveolar bone width were taken using CBCT scan at three stages; prior to grafting (T0) and immediately (T1), and 4 months post grafting (T2). Then three horizontal alveolar width measurements (crestal, middle and apical) were recorded at T0, T2 and T1. The measurement was performed with fixed points each time, the buccolingual width was measured at different levels. At the bone crest, 3mm from the bone crest and 6mm from the bone crest. The measurements were tabulated for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: Maxillary Alveolar Ridge AugmentationHorizontal bone augmentation will be done by bone shell technique |
| group B | Experimental | Procedure: Maxillary Alveolar Ridge AugmentationHorizontal bone augmentation will be done by autogenous tooth shell technique |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1- One or two maxillary extracted teeth with crestal bone width of 4 mm or less.
- 2- Age ranging from 1850 years 3- 3- Adequate oral hygiene. 4- Non smoking patients. 5-Free from any pathological lesions related to the tooth to be extracted. 6- Physically fit to withstand the whole procedure.
Key exclusion criteria (2 listed)
- 1- Active infection in the site to be treated. 2- Patients on chemotherapy or radiotherapy. 3- Alcohol or drug abuse. 4- Patients who have systemic disorders that interfere with bone healing {uncontrolled diabetes mellitus, autoimmune disease,
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 |
|---|---|---|
| Maxillary Alveolar Ridge Augmentationusing tooth graft or bone graft to increase alveolar ridge width to be able to insert dental implant | Procedure or surgery | group A, group B |
Primary outcome
horizontal alveolar width measurements
Time frame: 6 months
Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 40281533Awad KAI, Tawik MA, Hussein MM, El-Farag SAA, Sameaa SESA. Tooth shell versus bone shell technique for horizontal maxillary alveolar ridge augmentation. BMC Oral Health. 2025 Apr 25;25(1):642. doi: 10.1186/s12903-025-05940-4.
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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 Maxillary Alveolar Ridge Augmentation in people with Dental Implant, run by Mansoura 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 2 inclusion and 2 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 16 May 2024. 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?
Results are not available in the source record.
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?
horizontal alveolar width measurements (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 NCT06416605, 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 May 2024.