Implant StabilityNCT06992557
Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol
A study testing Biological drilling osteotomy protocol and Conventional drilling osteotomy protocol in people with Implant Stability and Low Speed Drilling, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of biological drilling osteotomy protocol compared to conventional osteotomy protocol in delayed implant placement in the posterior mandible regarding implant stability Type of study design: Randomized Clinical Trial In patient indicated for delayed implant placement in the lower… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Stability, Low Speed Drilling
- What is being tested?
- Biological drilling osteotomy protocol and Conventional drilling osteotomy protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy male and female patients, aged 21 to 60 years old,
- Indicated for delayed implant placement in the posterior mandibular arch.
- Good oral health.
- Willingness to sign the informed consent form.
Who cannot join
- Heavy smoker (> 10 cigarettes/day)
- Pregnant females
- Contraindication for Implant surgery.
- Patients with poor oral hygiene.
- A history of radiotherapy in the head or neck region.
- Patients with systemic disease like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol in the Mandibular Posterior Area a Randomized Controlled Trial
This study aims to evaluate the effect of biological drilling osteotomy protocol compared to conventional osteotomy protocol in delayed implant placement in the posterior mandible regarding implant stability Type of study design: Randomized Clinical Trial In patient indicated for delayed implant placement in the lower posterior mandible will the use of biological drilling protocol osteotomy compared to conventional drilling protocol osteotomy differ regarding implant stability at three months?
- Conditions
- Implant Stability, Low Speed Drilling
- Being tested
- Biological drilling osteotomy protocol, Conventional drilling osteotomy protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological drilling osteotomy protocolProcedure or surgery
- Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation.
- The implant will be positioned in the osteotomy site and a healing collar will be placed.
Conventional drilling osteotomy protocolProcedure or surgery
- Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation.
- The implant will be positioned in the osteotomy site and a healing collar will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Biological drilling osteotomy protocol | Experimental | * Local infiltration anesthesia will be applied to all the patients participating in this study.
* Full thickness mucoperiosteal flap reflection with 15c blade.
* Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.
* The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material Receives: Procedure: Biological drilling osteotomy protocol |
| Conventional drilling osteotomy protocol | Active comparator | * Local infiltration anesthesia will be applied to all the patients participating in this study.
* Full thickness mucoperiosteal flap reflection with 15c blade.
* Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.
* The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material. Receives: Procedure: Conventional drilling osteotomy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability (Implant Stability Quotient )
Scale ranges from 1 to 100, the higher the Implant stability quotient the more stability
Measured: Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgical
Secondary outcomes (4)
Crestal bone level changes
Long-cone intraoral radiographs were collected under controlled circumstances with personalised X-ray holders (XPC) and a registration bite block for repeatable imaging. The periapical radiographs carried out by digital sensor size 2 standardized film and standardized exposure settings The neck of the implant was taken as a reference point in all images for standardization post surgically and after 3 months.
Measured: Measurements will be taken immediately post surgical and after 3 months post surgical
Post-Operative Pain ( visual analogue scale)
Filled in by the patient after being given instructions about charting by the dental operator
Measured: 7 days post surgically
Post-operative swelling (Verbal rating scale)
Filled in by the patient after being given instructions about charting by the dental operator.
- Absent(no swelling)
- Slight (intraoral swelling at the operated area)
- Moderate (moderate intraoral swelling at the operated area)
- Intense (intensive extra oral swelling extending beyond the operated area).
Measured: Swelling will be assessed 7 days post surgically
Post-Operative patient's Satisfaction
Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure
Measured: 3 months post surgically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study startJun 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant StabilityStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazen Mostafa Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992557
- Sponsor's protocol ID
- mazenmostafasayedali@@15121987
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol in the Mandibular Posterior Area a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06992557
- Acronym / sponsor ID
- mazenmostafasayedali@@15121987
- Conditions
- Implant Stability, Low Speed Drilling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 28 May 2025 (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.
This study aims to evaluate the effect of biological drilling osteotomy protocol compared to conventional osteotomy protocol in delayed implant placement in the posterior mandible regarding implant stability Type of study design: Randomized Clinical Trial In patient indicated for delayed implant placement in the lower posterior mandible will the use of biological drilling protocol osteotomy compared to conventional drilling protocol osteotomy differ regarding implant stability at three months?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological drilling osteotomy protocol | Experimental | Procedure: Biological drilling osteotomy protocol* Local infiltration anesthesia will be applied to all the patients participating in this study. * Full thickness mucoperiosteal flap reflection with 15c blade. * Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation. * The implant will be positioned in the osteotomy site and a healing collar will be placed. * The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material |
| Conventional drilling osteotomy protocol | Active comparator | Procedure: Conventional drilling osteotomy protocol* Local infiltration anesthesia will be applied to all the patients participating in this study. * Full thickness mucoperiosteal flap reflection with 15c blade. * Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation. * The implant will be positioned in the osteotomy site and a healing collar will be placed. * The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically healthy male and female patients, aged 21 to 60 years old,
- Indicated for delayed implant placement in the posterior mandibular arch.
- Good oral health.
- Willingness to sign the informed consent form.
Key exclusion criteria (6 listed)
- Heavy smoker (> 10 cigarettes/day)
- Pregnant females
- Contraindication for Implant surgery.
- Patients with poor oral hygiene.
- A history of radiotherapy in the head or neck region.
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 |
|---|---|---|
| Biological drilling osteotomy protocol* Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation. * The implant will be positioned in the osteotomy site and a healing collar will be placed. | Procedure or surgery | Biological drilling osteotomy protocol |
| Conventional drilling osteotomy protocol* Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation. * The implant will be positioned in the osteotomy site and a healing collar will be placed. | Procedure or surgery | Conventional drilling osteotomy protocol |
Primary outcome
Implant stability (Implant Stability Quotient )
Time frame: Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgical
Scale ranges from 1 to 100, the higher the Implant stability quotient the more stability
4 secondary outcomes
Crestal bone level changes
Time frame: Measurements will be taken immediately post surgical and after 3 months post surgical
Post-Operative Pain ( visual analogue scale)
Time frame: 7 days post surgically
Post-operative swelling (Verbal rating scale)
Time frame: Swelling will be assessed 7 days post surgically
Post-Operative patient's Satisfaction
Time frame: 3 months post surgically
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological drilling osteotomy protocol and Conventional drilling osteotomy protocol in people with Implant Stability and Low Speed Drilling, 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 6 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: opening soon, as of the sponsor's last update on 28 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mazen Mostafa, master in periodontology (00201005305913, mazen.ali@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (Implant Stability Quotient ) (time frame: Measurements will be taken immediately post surgical ,3 weeks,2 month and 3 months post surgical). 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 28 May 2025.