Digital Guided Bone RegenerationRCTNCT06620367
Guided Sausage Technique in Bone Regeneration As a Novel Digital Work Flow
A study testing conventional guided bone regeneration and digital guided bone regeneration in people with Digital Guided Bone Regeneration, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide. The main questions it aims to answer are: Does it differ in amount of bone resorption between the conventional and digital guided bone… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digital Guided Bone Regeneration
- What is being tested?
- conventional guided bone regeneration and digital guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2024to 20 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medium horizontal ridge defect according to clone classification
- must have a general health showing no contraindications for surgery
- must be at least 35 years old
- patients also have adequate soft tissue thickness and width of keratinized gingiva
Who cannot join
- no sign of uncontrolled systemic diseases
- non smoker
- not pregnant
- sever ridge deficient
- patients below 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide
The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide. The main questions it aims to answer are:
- Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration?
- What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.
Read more
Participants will:
- Receive guided bone regeneration around implant
- Visit the clinic after 2,7,14 days for detection any signs of flap dehiscence
- Bone gain and bone density will be assessed after 6 months
Read the detailed description
Twenty sites with ridge defects will be recruited for this study. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for clinical approval. The purpose of the present study will be explained to the patients and informed consents will be obtained . Sites were randomly divided into 2 treatment groups .10 sites will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane without use of guide \& 10 sites will receive the same treatment except it will be guided using digitally designed guide. Membranes in both groups will be stabilized by tacks. Following clinical parameters will be recorded: the wound opening of buccolingual distance between sutured flap margins with a UNC periodontal probe to the nearest millimeter at 2, 7 and 14 days, flap dehiscence. Also, bone gain and bone density will be assessed using cone beam computed tomography (CBCT) at baseline and 6 months post-surgery. The collected data was statistically analyzed at the different follow up periods.
- Conditions
- Digital Guided Bone Regeneration
- Being tested
- conventional guided bone regeneration, digital guided bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional guided bone regenerationProcedure or surgery
10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane stabilized by tacks
digital guided bone regenerationProcedure or surgery
10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) placed by digital designed guide covered with bilayer collagen membrane stabilized by tacks
| Study group | Role | What they receive |
|---|---|---|
| conventional guided bone regeneration | Active comparator | a medium horizontal ridge defect will receive bone graft and covered with membrane Receives: Procedure: conventional guided bone regeneration |
| digital guided bone regeneration | Active comparator | digital designed guide will be used in a medium horizontal ridge defect to place bone graft and covered with membrane Receives: Procedure: digital guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
flap dehiscence
the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins
Measured: 14 days
Secondary outcomes (2)
bone gain
bone gain will be assessed using cone beam computed tomography (CBCT)
Measured: 6 months
bone denisty
cone beam computed tomography (CBCT) will be used to asses bone density
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 posted1 Oct 2024
- Study start20 Apr 2024
- Primary completion24 Sep 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Guided Bone RegenerationStudies of the same condition, open and under way.
- More trials run by Tanta 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Al-Ahmady El-Meligy, Tanta University
- Investigators
- Bassem nabil elfahl, assistant professor, Principal investigator, faculty of dentistry Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620367
- Sponsor's protocol ID
- #R-OMPDR- 6-24-3122
- Acronym
- RCT
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approach in Guided Bone Regeneration Using Digitally Designed Surgical Guide
- ClinicalTrials.gov ID
- NCT06620367
- Acronym / sponsor ID
- RCT / #R-OMPDR- 6-24-3122
- Conditions
- Digital Guided Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 24 Sep 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 1 Oct 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.
The goal of this clinical trial is to compare amount of bone resorption and flap dehiscence following guided bone regeneration with or without digitally designed surgical guide. The main questions it aims to answer are:
- Does it differ in amount of bone resorption between the conventional and digital guided bone regeneration?
- What is the difference between conventional and digital protocols regarding flap dehiscence following guided bone regeneration? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.
Participants will:
- Receive guided bone regeneration around implant
- Visit the clinic after 2,7,14 days for detection any signs of flap dehiscence
- Bone gain and bone density will be assessed after 6 months
Detailed description
Twenty sites with ridge defects will be recruited for this study. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for clinical approval. The purpose of the present study will be explained to the patients and informed consents will be obtained . Sites were randomly divided into 2 treatment groups .10 sites will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane without use of guide \& 10 sites will receive the same treatment except it will be guided using digitally designed guide. Membranes in both groups will be stabilized by tacks. Following clinical parameters will be recorded: the wound opening of buccolingual distance between sutured flap margins with a UNC periodontal probe to the nearest millimeter at 2, 7 and 14 days, flap dehiscence. Also, bone gain and bone density will be assessed using cone beam computed tomography (CBCT) at baseline and 6 months post-surgery. The collected data was statistically analyzed at the different follow up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional guided bone regeneration | Active comparator | Procedure: conventional guided bone regenerationa medium horizontal ridge defect will receive bone graft and covered with membrane |
| digital guided bone regeneration | Active comparator | Procedure: digital guided bone regenerationdigital designed guide will be used in a medium horizontal ridge defect to place bone graft and covered with membrane |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- medium horizontal ridge defect according to clone classification
- must have a general health showing no contraindications for surgery
- must be at least 35 years old
- patients also have adequate soft tissue thickness and width of keratinized gingiva
Key exclusion criteria (5 listed)
- no sign of uncontrolled systemic diseases
- non smoker
- not pregnant
- sever ridge deficient
- patients below 18 years old
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 |
|---|---|---|
| conventional guided bone regeneration10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) covered with bilayer collagen membrane stabilized by tacks | Procedure or surgery | conventional guided bone regeneration |
| digital guided bone regeneration10 sites with medium horizontal ridge defect will be treated with bone graft (50%autogenous mixed with 50%xenograft) placed by digital designed guide covered with bilayer collagen membrane stabilized by tacks | Procedure or surgery | digital guided bone regeneration |
Primary outcome
flap dehiscence
Time frame: 14 days
the flap dehiscence will be assessed using a UNC periodontal probe through the the wound opening of buccolingual distance between sutured flap margins
2 secondary outcomes
bone gain
Time frame: 6 months
bone denisty
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Digital Guided Bone Regeneration
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
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.
Bassem nabil elfahl, assistant professor principal investigator
faculty of dentistry Tanta university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional guided bone regeneration and digital guided bone regeneration in people with Digital Guided Bone Regeneration, run by Tanta 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 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: status not confirmed, as of the sponsor's last update on 1 Oct 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?
flap dehiscence (time frame: 14 days). 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 Oct 2024.