AugmentationPhase 4ClinicalNCT04266652
Using the Roots of a Non Restorable Wisdom Tooth as a Block for Augmentation of Localized Defects
A Phase 4 study testing tooth block and autogenous bone block in people with Augmentation, run by Ain Shams University at 1 site in Egypt.
Trial summary
assess and compare the efficacy and safety of autogenous tooth roots for lateral alveolar ridge augmentation with staged implant placement in comparison to autogenous bone block. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Augmentation
- What is being tested?
- tooth block and autogenous bone block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2018to 30 Sep 2020
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidate for lateral ridge augmentation
- Insufficient bone ridge width at the recipient site for implant placement
- Sufficient bone height at the recipient site for implant placement
- Healthy oral mucosa, at least 3 mm keratinized tissue.
- Presence of wisdom teeth free from periapical infection.
- Missing maxillary or mandibular tooth with moderate horizontal defect (4-8) according to cologne classification
Who cannot join
- 1) Patients are systemically free according to Modified Cornell Medical Index 2) smokers patients. 3) Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Abbassia, 11566
Laila El Raee, B.D.S, +201280967588, lelraee@msa.eun.eg
About this study
Official title: The Effect of Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement (A Controlled Clinical Study With Histological Assessment)
assess and compare the efficacy and safety of autogenous tooth roots for lateral alveolar ridge augmentation with staged implant placement in comparison to autogenous bone block.
Read the detailed description
A total of 14 patients in need of implant therapy and lateral ridge augmentation were allocated to parallel groups receiving either 1) healthy autogenous tooth roots (e.g. retained wisdom or impacted teeth or 2) cortical autogenous bone blocks harvested from the retromolar area. After 26 weeks of submerged healing the horizontal bone gain were assessed both clinically and radiographically. A core biopsy was taken during the implant placement to assess the histology of the newly formed bone.
- Conditions
- Augmentation
- Being tested
- tooth block, autogenous bone block
- Keywords
- tooth block, Dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth blockProcedure or surgery
tooth root blocks were used to increase the bone width
autogenous bone blockProcedure or surgery
autogenous bone block were used to increase the bone width
| Study group | Role | What they receive |
|---|---|---|
| Autogenous bone block | Experimental | the monocortical block grafts were harvested from the retromolar region (i.e. linea oblique) by using of rotating (i.e. carbide burs) Receives: Procedure: autogenous bone block |
| Tooth block | Experimental | In the first group, a second mucoperiosteal flap was elevated to surgically remove the respective wisdom tooth. After its removal and during the same surgery, the crown was decapitated at the cemento -enamel junction using a rotating carbide bur under gentle sterile saline cooling and the exposed pulp was preserved. The separated tooth root was adapted to match the size and shape of the defect area. To improve ankylosis between the graft and the defect site, the layer of cementum at the respective downward aspects of the root was carefully removed using a diamond bur until the underlying dentin was entirely exposed Receives: Procedure: tooth block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic assessment of alveolar bone width following autogenous tooth roots augmentation.
Measured: 6 months postoperatively
Secondary outcomes (1)
Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation. Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start6 Jan 2018
- Primary completion15 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AugmentationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Adel Salah Khattab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266652
- Sponsor's protocol ID
- 121734
- Acronym
- Clinical
- Status last verified
- Jul 2020
- First submitted
- 29 Jan 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement (A Controlled Clinical Study With Histological Assessment)
- ClinicalTrials.gov ID
- NCT04266652
- Acronym / sponsor ID
- Clinical / 121734
- Conditions
- Augmentation
- Keywords
- tooth block, Dental implants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Jan 2018 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 12 Feb 2020 (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.
assess and compare the efficacy and safety of autogenous tooth roots for lateral alveolar ridge augmentation with staged implant placement in comparison to autogenous bone block.
Detailed description
A total of 14 patients in need of implant therapy and lateral ridge augmentation were allocated to parallel groups receiving either 1) healthy autogenous tooth roots (e.g. retained wisdom or impacted teeth or 2) cortical autogenous bone blocks harvested from the retromolar area. After 26 weeks of submerged healing the horizontal bone gain were assessed both clinically and radiographically. A core biopsy was taken during the implant placement to assess the histology of the newly formed bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous bone block | Experimental | Procedure: autogenous bone blockthe monocortical block grafts were harvested from the retromolar region (i.e. linea oblique) by using of rotating (i.e. carbide burs) |
| Tooth block | Experimental | Procedure: tooth blockIn the first group, a second mucoperiosteal flap was elevated to surgically remove the respective wisdom tooth. After its removal and during the same surgery, the crown was decapitated at the cemento -enamel junction using a rotating carbide bur under gentle sterile saline cooling and the exposed pulp was preserved. The separated tooth root was adapted to match the size and shape of the defect area. To improve ankylosis between the graft and the defect site, the layer of cementum at the respective downward aspects of the root was carefully removed using a diamond bur until the underlying dentin was entirely exposed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Candidate for lateral ridge augmentation
- Insufficient bone ridge width at the recipient site for implant placement
- Sufficient bone height at the recipient site for implant placement
- Healthy oral mucosa, at least 3 mm keratinized tissue.
- Presence of wisdom teeth free from periapical infection.
Key exclusion criteria (1 listed)
- 1) Patients are systemically free according to Modified Cornell Medical Index 2) smokers patients. 3) Pregnant or lactating women.
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 |
|---|---|---|
| tooth blocktooth root blocks were used to increase the bone width | Procedure or surgery | Tooth block |
| autogenous bone blockautogenous bone block were used to increase the bone width | Procedure or surgery | Autogenous bone block |
Primary outcome
Clinical and radiographic assessment of alveolar bone width following autogenous tooth roots augmentation.
Time frame: 6 months postoperatively
1 secondary outcome
Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation. Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation.
Time frame: 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tooth block and autogenous bone block in people with Augmentation, run by Ain Shams 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 6 inclusion and 1 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 22 Jul 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographic assessment of alveolar bone width following autogenous tooth roots augmentation. (time frame: 6 months postoperatively). 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 22 Jul 2020.