Guided Bone RegenerationNCT06257225
Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patient Comparing the Stabilization of Membranes With and Without Tacs
A study testing Guided Bone regeneration in people with Guided Bone Regeneration, run by Cairo University.
Trial summary
To address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration
- What is being tested?
- Guided Bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 30 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with at least 1 missing tooth in the posterior mandibular area Patients with an age above 18 years Systemically healthy patients
- Healed alveolar ridge for implant placement with:
- Deficient buccolingual dimension ( ≤5mm)
- Sufficient vertical height (≥ 10 mm)
- Sufficient mesio-distal width (≥ 6.5 mm) Inter-arch space ≥ 7 mm to allow space for implant-supported crown Presence of neighboring and opposing dentition Soft tissue phenotype with keratinized tissue width (KTW) (≥2 mm) and gingival thickness (≥2 mm) Good oral hygiene Cooperative patients who accepted the trial follow up period and sign the informed consen
Who cannot join
- Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing Untreated periodontal diseases History of radiation therapy to the head and neck Heavy smokers (≥ 10 cigarettes per day) Pregnant or lactating females Alcoholism or drug abuse Psychiatric problems Patients with signs of acute infection related to the area of interest
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radiographic And Clinical Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patients Comparing the Stabilization of The Resorbable Collagen Membrane With and Without Tacs
To address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization
- Conditions
- Guided Bone Regeneration
- Being tested
- Guided Bone regeneration
- Keywords
- GBR, Tacs
- Medical subject headings
- Spondylocostal Dysostosis 4, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Bone regenerationProcedure or surgery
After local anesthesia, a crestal incision will be performed followed by full-thickness mucoperiosteal flap elevation Flap advancement will be attained through periosteal scoring of the buccal; The resorbable collagen membrane (Bio Gide, Geistlich AG) will be trimmed to the defect size. Xenograft (Bio-Oss) together with scrapped autogenous bone will be mixed and placed at the surgical site. The membrane will positioned over the graft and tucked into the lingual flap. Patient allocation concealment will be broken and the patients will be randomly assigned into two groups Patients receiving horizontal bone augmentation with resorbable collagen membrane stabilized with no tacks. The first layer will be closed with horizontal mattress sutures placed 4 mm from the incision line, and single interrupted sutures are used to close the edges of the flap. Vertical incisions are closed using single interrupted sutures and mattress suture should remain in place for at least 2 to 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patient showing horizontal defect and treated with GBR stabilized with Tacs | Active comparator | Fixation Receives: Procedure: Guided Bone regeneration |
| Patient showing horizontal defect and treated with GBR stabilized with no Tacs | Experimental | No Fixation Receives: Procedure: Guided Bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone gain assessed radiographically (mm)
Using CBCT
Measured: Baseline , 4 month
Secondary outcomes (6)
Horizontal bone gain assessed clinically (mm)
Bone Caliper
Measured: Baseline , 4 month
Amount of Pain
Visual Analogue Scale (VAS) (Price et al., 1983)
Measured: 7 days
Amount of Pain
Number of analgesics consumed daily for 7 days
Measured: 7 days
Patient satisfaction
Questionnaire - Binary
Measured: 4 month
Surgical Time
Stop Watch
Measured: During Surgery
Histological Evaluation
Core Biopsy
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University
- Responsible party
- Principal investigator, Hani Elnahass, Misr International University
- Investigators
- Hani ElNahass, PhD, Principal investigator, Cairo UniversityOmnia Tawfik, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257225
- Sponsor's protocol ID
- PerioMIU1029
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will check with Study chair
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic And Clinical Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patients Comparing the Stabilization of The Resorbable Collagen Membrane With and Without Tacs
- ClinicalTrials.gov ID
- NCT06257225
- Acronym / sponsor ID
- PerioMIU1029
- Conditions
- Guided Bone Regeneration
- Keywords
- GBR, Tacs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Misr International University
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Feb 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 address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient showing horizontal defect and treated with GBR stabilized with Tacs | Active comparator | Procedure: Guided Bone regenerationFixation |
| Patient showing horizontal defect and treated with GBR stabilized with no Tacs | Experimental | Procedure: Guided Bone regenerationNo Fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with at least 1 missing tooth in the posterior mandibular area Patients with an age above 18 years Systemically healthy patients
- Deficient buccolingual dimension ( ≤5mm)
- Sufficient vertical height (≥ 10 mm)
- Sufficient mesio-distal width (≥ 6.5 mm) Inter-arch space ≥ 7 mm to allow space for implant-supported crown Presence of neighboring and opposing dentition Soft tissue phenotype with keratinized tissue width (KTW) (≥2 mm) and gingival thickness (≥2 mm) Good oral hygiene Cooperative patients who accepted the trial follow up period and sign the informed consen
Key exclusion criteria (1 listed)
- Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing Untreated periodontal diseases History of radiation therapy to the head and neck Heavy smokers (≥ 10 cigarettes per day) Pregnant or lactating females Alcoholism or drug abuse Psychiatric problems Patients with signs of acute infection related to the area of interest
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 |
|---|---|---|
| Guided Bone regenerationAfter local anesthesia, a crestal incision will be performed followed by full-thickness mucoperiosteal flap elevation Flap advancement will be attained through periosteal scoring of the buccal; The resorbable collagen membrane (Bio Gide, Geistlich AG) will be trimmed to the defect size. Xenograft (Bio-Oss) together with scrapped autogenous bone will be mixed and placed at the surgical site. The membrane will positioned over the graft and tucked into the lingual flap. Patient allocation concealment will be broken and the patients will be randomly assigned into two groups Patients receiving horizontal bone augmentation with resorbable collagen membrane stabilized with no tacks. The first layer will be closed with horizontal mattress sutures placed 4 mm from the incision line, and single interrupted sutures are used to close the edges of the flap. Vertical incisions are closed using single interrupted sutures and mattress suture should remain in place for at least 2 to 3 weeks | Procedure or surgery | Patient showing horizontal defect and treated with GBR stabilized with Tacs, Patient showing horizontal defect and treated with GBR stabilized with no Tacs |
Primary outcome
Horizontal bone gain assessed radiographically (mm)
Time frame: Baseline , 4 month
Using CBCT
6 secondary outcomes
Horizontal bone gain assessed clinically (mm)
Time frame: Baseline , 4 month
Amount of Pain
Time frame: 7 days
Amount of Pain
Time frame: 7 days
Patient satisfaction
Time frame: 4 month
Surgical Time
Time frame: During Surgery
Histological Evaluation
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Undecided. I will check with Study chair
Related trials for Guided Bone Regeneration
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Clinical Efficacy Assessment of Digitally Fabricated PEEK Barrier Membranes for Guided Bone Regeneration in Severe Bone Defects
Guided Bone Regeneration
Not yet recruitingObservational study
Impact of Gingival Phenotype on Guided Bone Regeneration in the Maxillary Anterior Region
Guided Bone Regeneration
Active, not recruitingObservational study
Evaluation of Bone Regeneration Outcomes Following Guided Bone Regeneration in the Anterior Maxillary Region
Implant Placement in Maxillary Esthetic Zone
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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.
Hani ElNahass, PhD principal investigator
Cairo University
Omnia Tawfik, PhD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Guided Bone regeneration in people with Guided Bone Regeneration, run by Cairo University.
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 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yahya Amer, PhD (+201006194329, yahia.hassan@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone gain assessed radiographically (mm) (time frame: Baseline , 4 month). 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 13 Feb 2024.