Tooth ExtractionNCT05708196
Evaluation of β-tricalcium Phosphate/Calcium Sulfate Versus Allografts
A study testing Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK). and Allograft bone grafting material. in people with Tooth Extraction, run by Mansoura University at 1 site in Egypt.
Trial summary
Thirty healthy patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, to be included in this study with non-restorable posterior teeth.Patients will be selected according to the following criteria: 1) having a non-restorable… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK). and Allograft bone grafting material.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Oct 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having a non-restorable posterior tooth.
- being healthy, with no systemic diseases that might contraindicate receiving a dental implant.
- having good oral hygiene.
- aged between 18 to 45 years old.
- having sufficient alveolar bone volume and height at the future implant site
Who cannot join
- having received radiation therapy at the head and neck area or chemotherapy in the past 12 months.
- having uncontrolled diabetes.
- having poor oral hygiene or motivation.
- having bruxism or other parafunctional habit.
- having infection or inflammation at the proposed implant site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of β-tricalcium Phosphate/Calcium Sulfate Versus Allografts in Implant Bone Reconstructive Procedures; A Histological and Radiographical Clinical Trial.
Thirty healthy patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, to be included in this study with non-restorable posterior teeth.Patients will be selected according to the following criteria: 1) having a non-restorable posterior tooth. 2) being healthy, with no systemic diseases that might contraindicate receiving a dental implant. 3) having good oral hygiene. 4) aged between 18 to 45 years old. 5) having sufficient alveolar bone volume and height at the future implant site.Patients were classified into three groups:
- Group I: ten extraction sockets left for normal healing (blood clot).
- Group II: ten extraction sockets filled with Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).
- Group III: ten extraction sockets filled with Allograft bone grafting material.Evaluation and Follow-up
Read more
All patients will be evaluated clinically and radiographically during a follow up period of 4 months, where the following criteria will be evaluated:
A- Clinical evaluation:
- Patients will be evaluated at 1 week, 4 weeks and 8 weeks.
- Clinical evaluations of soft tissue healing, and keratinized tissue replacement will be assessed on the basis of the healing index proposed by Landry et al12.
- The scores will assess healing on the basis of redness, presence of granulation tissue, bleeding, suppuration, and epithelization.
- The surgical region will be examined clinically, if there is pain, redness, tissue resorption and bone graft stability.
B- Radiographic evaluation:
- Cone Beam Computed Tomography scan will be taken immediately after implant placement, and after 12 months.
- All patient scans will be taken by a Planmeca ProMax 3D unit (Planmeca OY, Helsinki, Finland) using fixed imaging parameter at every scan. All DICOM data will then be analyzed using On Demand 3D software (Version 1, Cyber Med, Seoul, South Korea).
- The vertical and horizontal measurements will be measured.
- The apico-coronal dimension will be calculated, the bottom of the socket will be considered the most apical point, whereas the alveolar bone margin will be considered the most coronal point of the socket bone wall.
C- Histological evaluation:
- Bone samples will be collected with trephine bur before implant placement, then fixed in 10% neutral buffered formalin for 24 hours, then transferred to 14% neutral buffered Ethylenediaminetetraacetic acid (EDTA) for decalcification 13. After confirming adequate decalcification, the specimens will be processed and embedded in paraffin blocks in the Pathology department, faculty of Medicine, Mansoura university for histological assessment, then stained with haematoxylin and eosin (H\&E) as a routine stain to evaluate the quality of newly formed bone.
- Conditions
- Tooth Extraction
- Being tested
- Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK)., Allograft bone grafting material.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).Other
After tooth extraction, the tooth socket will begrafted with Alloplast grafting material
Allograft bone grafting material.Other
After tooth extraction, the tooth socket will be grafted with allograft grafting material
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | ten extraction sockets left for normal healing (blood clot). |
| group 2 | Experimental | ten extraction sockets filled with Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK). Receives: Other: Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK). |
| group 3 | Experimental | ten extraction sockets filled with Allograft bone grafting material. Receives: Other: Allograft bone grafting material. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density measurement
CBCT will be used to assess bone density categories and HU
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jun 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2022
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.
- More trials run by Mansoura 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT05708196
- Sponsor's protocol ID
- M23011122
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of β-tricalcium Phosphate/Calcium Sulfate Versus Allografts in Implant Bone Reconstructive Procedures; A Histological and Radiographical Clinical Trial.
- ClinicalTrials.gov ID
- NCT05708196
- Acronym / sponsor ID
- M23011122
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 1 Feb 2023 (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.
Thirty healthy patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, to be included in this study with non-restorable posterior teeth.Patients will be selected according to the following criteria: 1) having a non-restorable posterior tooth. 2) being healthy, with no systemic diseases that might contraindicate receiving a dental implant. 3) having good oral hygiene. 4) aged between 18 to 45 years old. 5) having sufficient alveolar bone volume and height at the future implant site.Patients were classified into three groups:
- Group I: ten extraction sockets left for normal healing (blood clot).
- Group II: ten extraction sockets filled with Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).
- Group III: ten extraction sockets filled with Allograft bone grafting material.Evaluation and Follow-up
All patients will be evaluated clinically and radiographically during a follow up period of 4 months, where the following criteria will be evaluated:
A- Clinical evaluation:
- Patients will be evaluated at 1 week, 4 weeks and 8 weeks.
- Clinical evaluations of soft tissue healing, and keratinized tissue replacement will be assessed on the basis of the healing index proposed by Landry et al12.
- The scores will assess healing on the basis of redness, presence of granulation tissue, bleeding, suppuration, and epithelization.
- The surgical region will be examined clinically, if there is pain, redness, tissue resorption and bone graft stability.
B- Radiographic evaluation:
- Cone Beam Computed Tomography scan will be taken immediately after implant placement, and after 12 months.
- All patient scans will be taken by a Planmeca ProMax 3D unit (Planmeca OY, Helsinki, Finland) using fixed imaging parameter at every scan. All DICOM data will then be analyzed using On Demand 3D software (Version 1, Cyber Med, Seoul, South Korea).
- The vertical and horizontal measurements will be measured.
- The apico-coronal dimension will be calculated, the bottom of the socket will be considered the most apical point, whereas the alveolar bone margin will be considered the most coronal point of the socket bone wall.
C- Histological evaluation:
- Bone samples will be collected with trephine bur before implant placement, then fixed in 10% neutral buffered formalin for 24 hours, then transferred to 14% neutral buffered Ethylenediaminetetraacetic acid (EDTA) for decalcification 13. After confirming adequate decalcification, the specimens will be processed and embedded in paraffin blocks in the Pathology department, faculty of Medicine, Mansoura university for histological assessment, then stained with haematoxylin and eosin (H\&E) as a routine stain to evaluate the quality of newly formed bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –ten extraction sockets left for normal healing (blood clot). |
| group 2 | Experimental | Other: Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).ten extraction sockets filled with Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK). |
| group 3 | Experimental | Other: Allograft bone grafting material.ten extraction sockets filled with Allograft bone grafting material. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- having a non-restorable posterior tooth.
- being healthy, with no systemic diseases that might contraindicate receiving a dental implant.
- having good oral hygiene.
- aged between 18 to 45 years old.
- having sufficient alveolar bone volume and height at the future implant site
Key exclusion criteria (5 listed)
- having received radiation therapy at the head and neck area or chemotherapy in the past 12 months.
- having uncontrolled diabetes.
- having poor oral hygiene or motivation.
- having bruxism or other parafunctional habit.
- having infection or inflammation at the proposed implant site.
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 |
|---|---|---|
| Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).After tooth extraction, the tooth socket will begrafted with Alloplast grafting material | Other | group 2 |
| Allograft bone grafting material.After tooth extraction, the tooth socket will be grafted with allograft grafting material | Other | group 3 |
Primary outcome
Bone density measurement
Time frame: 4 months
CBCT will be used to assess bone density categories and HU
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 1 Feb 2023.
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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 Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK). and Allograft bone grafting material. in people with Tooth Extraction, 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 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 1 Feb 2023. 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?
Bone density measurement (time frame: 4 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 1 Feb 2023.