Anterior Labial Wall DefectEarly Phase 1NCT05162885
Effect of Sodium Alendronate on the Final Implant Stability.
A Early Phase 1 study testing Socket Preservation technique in people with Anterior Labial Wall Defect, run by Cairo University at 1 site in Egypt.
Trial summary
evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Labial Wall Defect
- What is being tested?
- Socket Preservation technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Oct 2022
- Phase
- Early Phase 1
- 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 seeking implant drive prosthesis after socket has been preserved by either technique.
- Patients with seeking implant drive prosthesis with Salama Class 3 defective sockets.
- Both genders males and females will be included.
Who cannot join
- General contraindications to implant surgery.
- Patient seeking immediate implant placement.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
Show all 16Show fewer
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Active infection or severe inflammation in the area intended for implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly
- followed. Referred only for implant placement or unable to attend a 5-year follow-up
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hossam Abdallah Mohammed Ghazally
Cairo, Manial, 11553
Nadia Galal Galal, PHD, 01002177637 ext. 0020, Nadia.Galal@dentistry.cu.edu.eg
Nadia Galal Galal, PHD
About this study
Official title: Effect of Sodium Alendronate Versus Sticky Bone as Socket Preservation Materials on the Final Implant Stability. A Randomized Clinical Trial
evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials
Read the detailed description
compare the stability of implant placement using Osstell ISQ "resonance frequency analyzer", and marginal bone resorption and bone density around implant by X-ray analysis in different socket preservation techniques comparing sodium alendronate with the sticky bone graft technique
- Conditions
- Anterior Labial Wall Defect
- Being tested
- Socket Preservation technique
- Keywords
- Stability, Sodium Alendronate, Implant, Sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket Preservation techniqueProcedure or surgery
Also called Implant in socket preserved with sodium alenderonate drug
Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama\&salama Class 3 labial wall defect
| Study group | Role | What they receive |
|---|---|---|
| implant placement in defective Sockets preserved with alendronic acid sponge | Active comparator | anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier.
The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material. Receives: Procedure: Socket Preservation technique |
| Implant placement in Defective sockets preserved with sticky bone | Active comparator | anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier.
The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material. Receives: Procedure: Socket Preservation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Calculate the final implant stability of two groups using Osstell "resonance frequency analyzer"
Measured: 3-4 months after Dental implant placement
Secondary outcomes (1)
marginal bone
Evaluation of marginal bone resorption around implant in two groups using superimposition x-ray (CBCT) software analysis
Measured: 3-4 months after Dental implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 May 2021
- Primary completion23 May 2021
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Labial Wall DefectStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Abdallah Mohammed Ghazzaly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162885
- Sponsor's protocol ID
- omfs335
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Alendronate Versus Sticky Bone as Socket Preservation Materials on the Final Implant Stability. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05162885
- Acronym / sponsor ID
- omfs335
- Conditions
- Anterior Labial Wall Defect
- Keywords
- Stability, Sodium Alendronate, Implant, Sticky bone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 23 May 2021 (actual)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 17 Dec 2021 (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.
evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials
Detailed description
compare the stability of implant placement using Osstell ISQ "resonance frequency analyzer", and marginal bone resorption and bone density around implant by X-ray analysis in different socket preservation techniques comparing sodium alendronate with the sticky bone graft technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant placement in defective Sockets preserved with alendronic acid sponge | Active comparator | Procedure: Socket Preservation techniqueanesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier. The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material. |
| Implant placement in Defective sockets preserved with sticky bone | Active comparator | Procedure: Socket Preservation techniqueanesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier. The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with seeking implant drive prosthesis after socket has been preserved by either technique.
- Patients with seeking implant drive prosthesis with Salama Class 3 defective sockets.
- Both genders males and females will be included.
Key exclusion criteria (16 listed)
- General contraindications to implant surgery.
- Patient seeking immediate implant placement.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
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 |
|---|---|---|
| Socket Preservation techniqueAlso: Implant in socket preserved with sodium alenderonate drugImplant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama\&salama Class 3 labial wall defect | Procedure or surgery | Implant placement in Defective sockets preserved with sticky bone, implant placement in defective Sockets preserved with alendronic acid sponge |
Primary outcome
Implant stability
Time frame: 3-4 months after Dental implant placement
Calculate the final implant stability of two groups using Osstell "resonance frequency analyzer"
1 secondary outcome
marginal bone
Time frame: 3-4 months after Dental implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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 Early Phase 1 study testing Socket Preservation technique in people with Anterior Labial Wall Defect, 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 3 inclusion and 16 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 17 Dec 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Implant stability (time frame: 3-4 months after Dental implant placement). 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 17 Dec 2021.