Posterior Atrophic MandibleNCT06443476
Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible
A study testing Tenting abutment technique and Tent pole technique in people with Posterior Atrophic Mandible, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Atrophic Mandible
- What is being tested?
- Tenting abutment technique and Tent pole technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Oct 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with atrophic posterior mandible.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicates implant placement
Who cannot join
- Local criteria:
- Untreated gingivitis, periodontitis.
- Insufficient oral hygiene.
- Previous radiation therapy for the head and neck neoplasia, or bone augmentation to implant site..
- Systemic criteria:
- Systemic disorders.
Show all 9Show fewer
- Heavy smoking of more than 20 cigarettes per day.
- Bone pathology.
- ·Psychiatric problems. Emotional instability. Unrealistic aesthetic demands.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alaa Mohammed Hafedh
Cairo
Alaa Mohammed Hafedh, Master, 01008164907, alaabenhafeed@gmail.com
About this study
Official title: A Comparative Study Between Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible Randomized Clinical Trial
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.
The tent pole provides excellent mechanical properties; stability \& fixation, yet very poor features to preserve the integrity of the soft tissue.
Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole.
Read the detailed description
Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation.
Xenograft bone has been utilized for the reconstruction of large 3-dimensional defects because it has no donor site morbidity and is of an unlimited volume in quantity.
Guided bone regeneration (GBR) describes the use of membranes to regenerate bony defects. A membrane for GBR needs to be biocompatible, cell occlusive, non-toxic, moldable and possess space-maintaining properties including stability.
- e. Explanation for choice of comparators (conventional titanium mesh): Tent pole offers superb mechanical properties for guided bone regeneration treatment in larger areas and it is regarded one of the most available covers for guided bone regeneration yet one of the cheapest.
- Objectives:
- a. Aim of the study:
- To evaluate the quantity of gained bone under tenting abutment compared to a tent pole.
- To evaluate amount of wound dehiscence postoperatively using tenting abutment technique compared to a tent pole.
- ·To optimize the anatomical situation in order to facilitate implant installation.
7b. Hypothesis:
- Bone is a dynamic and living tissue with the capacity to repair and regenerate in response to injury. It is further possible to guide bone cells into an area that previously consisted of bony tissue to regenerate bone and increase the bone volume.
- Tenting abutment is suitable as a biomaterial for creating a space between the bone cortex and the periosteum to enhance new bone regeneration.
- Tenting abutment material will enhance the quantity and quality of newly formed bone.
- Tenting abutment will cause less soft tissue dehiscence and will dramatically decrease the percentage of the collapse of the space produced by the bone graft and minimizes resorption of the grafting material compared to the titanium mesh. 7c. Primary and secondary objectives:
- Primary objective: Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using tenting abutment technique compared to tent pole.
- Secondary objectives:
Evaluation of soft tissue dehiscence and resorption of the grafting material that might occur using tent pole compared to the tenting abutment.
- Conditions
- Posterior Atrophic Mandible
- Being tested
- Tenting abutment technique, Tent pole technique
- Keywords
- SANTA, tent abutment, Tent pole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenting abutment techniqueProcedure or surgery
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.
Tent pole techniqueProcedure or surgery
using the Tent pole technique to gain bone vertical and horizontal loss
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | Using a tent pole to gain bone in the atrophic posterior mandible. Receives: Procedure: Tent pole technique |
| study group | Active comparator | Using a Tenting abutment to gain bone in the atrophic posterior mandible Receives: Procedure: Tenting abutment technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
height gained and width gained
height gained and width gained Measure unit milimerter (mm) Measure device :CBCT
Measured: before and post operative four months
Secondary outcomes (1)
Soft tissue dehiscence
measure clinically (yes-no)
Measured: after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Oct 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Atrophic MandibleStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using the tenting abutment technique compared to the tent pole
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohmmed Salem Hafedh, Cairo University
- Investigators
- Mohamed ahmed Farid shehab, professor, Study director, supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443476
- Sponsor's protocol ID
- OMFS (3-3-5)
- Status last verified
- Jun 2023
- First submitted
- 30 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06443476
- Acronym / sponsor ID
- OMFS (3-3-5)
- Conditions
- Posterior Atrophic Mandible
- Keywords
- SANTA, tent abutment, Tent pole
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Jun 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.
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.
The tent pole provides excellent mechanical properties; stability \& fixation, yet very poor features to preserve the integrity of the soft tissue.
Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole.
Detailed description
Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation.
Xenograft bone has been utilized for the reconstruction of large 3-dimensional defects because it has no donor site morbidity and is of an unlimited volume in quantity.
Guided bone regeneration (GBR) describes the use of membranes to regenerate bony defects. A membrane for GBR needs to be biocompatible, cell occlusive, non-toxic, moldable and possess space-maintaining properties including stability.
- e. Explanation for choice of comparators (conventional titanium mesh): Tent pole offers superb mechanical properties for guided bone regeneration treatment in larger areas and it is regarded one of the most available covers for guided bone regeneration yet one of the cheapest.
- Objectives:
- a. Aim of the study:
- To evaluate the quantity of gained bone under tenting abutment compared to a tent pole.
- To evaluate amount of wound dehiscence postoperatively using tenting abutment technique compared to a tent pole.
- ·To optimize the anatomical situation in order to facilitate implant installation.
7b. Hypothesis:
- Bone is a dynamic and living tissue with the capacity to repair and regenerate in response to injury. It is further possible to guide bone cells into an area that previously consisted of bony tissue to regenerate bone and increase the bone volume.
- Tenting abutment is suitable as a biomaterial for creating a space between the bone cortex and the periosteum to enhance new bone regeneration.
- Tenting abutment material will enhance the quantity and quality of newly formed bone.
- Tenting abutment will cause less soft tissue dehiscence and will dramatically decrease the percentage of the collapse of the space produced by the bone graft and minimizes resorption of the grafting material compared to the titanium mesh. 7c. Primary and secondary objectives:
- Primary objective: Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using tenting abutment technique compared to tent pole.
- Secondary objectives:
Evaluation of soft tissue dehiscence and resorption of the grafting material that might occur using tent pole compared to the tenting abutment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using the tenting abutment technique compared to the tent pole
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Procedure: Tent pole techniqueUsing a tent pole to gain bone in the atrophic posterior mandible. |
| study group | Active comparator | Procedure: Tenting abutment techniqueUsing a Tenting abutment to gain bone in the atrophic posterior mandible |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with atrophic posterior mandible.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicates implant placement
Key exclusion criteria (9 listed)
- Local criteria:
- Systemic disorders.
- Heavy smoking of more than 20 cigarettes per day.
- Bone pathology.
- ·Psychiatric problems. Emotional instability. Unrealistic aesthetic demands.
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 |
|---|---|---|
| Tenting abutment techniqueTo evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible. | Procedure or surgery | study group |
| Tent pole techniqueusing the Tent pole technique to gain bone vertical and horizontal loss | Procedure or surgery | conventional group |
Primary outcome
height gained and width gained
Time frame: before and post operative four months
height gained and width gained Measure unit milimerter (mm) Measure device :CBCT
1 secondary outcome
Soft tissue dehiscence
Time frame: after one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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.
Mohamed ahmed Farid shehab, professor study director
supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenting abutment technique and Tent pole technique in people with Posterior Atrophic Mandible, run by Cairo 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 4 inclusion and 9 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 5 Jun 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?
Contact alaa Mohammed Hafedh, master (+201008164907, alaabenhafeed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
height gained and width gained (time frame: before and post operative four 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 5 Jun 2024.