ImplantNCT06770231
Peri-implant Bone Behaviour Using Two Drilling Techniques in Posterior Maxilla
A study testing Single drill system in people with Implant, run by Mansoura University at 1 site in Egypt.
Trial summary
Two different drilling techniques in posterior maxilla immediate loading implant Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant
- What is being tested?
- Single drill system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2023to 30 Aug 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 missing single or multiple teeth in posterior maxilla.
- Age more than 18 years.
- 10 mm or more vertical bone height is present.
- Good oral hygiene.
- Patients willing to be present during the study follow up intervals.
- Patients free from any systemic diseases.
Show all 9Show fewer
- 6 mm or more ridge width is present.
- Crown height space of at least 8 mm.
- Patients without any para-functional habits (bruxism and clenching).
Who cannot join
- Patients with any pathological lesion or root tips at the planned surgical site.
- Patients with inadequate bone height and thickness.
- Smoking more than 14 cigarettes per day.14
- Alcohol or drug abuse.
- Patients with systemic diseases that absolutely contraindicate implant placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-implant Bone Behavior After Single Drilling Technique Versus Undersized Technique of Immediately Loaded Implant in Posterior Maxilla: A One-year Prospective Study
Two different drilling techniques in posterior maxilla immediate loading implant
Read the detailed description
One of the surgical techniques used to enhance the primary stability of implant in low density bone was the undersized drilling technique, which has been introduced to locally optimize poor density of bone by using a final drill diameter considerably smaller compared with the implant diameter.
On the other hand, a novel hollow drill with a single drilling systems was designed. Single drilling technique shortens surgical times, removes the smallest amount of bone during implant site preparation, reduces bone damage and micro fractures, and speeds up the healing process. Additionally, because of the hollow shape, bone core may be harvested and used as an autogenous bone grafting material.
- Conditions
- Implant
- Being tested
- Single drill system
- Keywords
- Implant stability, Immediate loading, Single drilling technique, Posterior maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single drill systemOther
New system for drilling
| Study group | Role | What they receive |
|---|---|---|
| Undersized technique | Experimental | New drilling tech Receives: Other: Single drill system |
| Single drill technique | Active comparator | One drill system Receives: Other: Single drill system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Implant stability will be assessed at the time of implant insertion and at 3, 6 and 12 months after surgery.
Measured: 12 months
Modified Sulcus Bleeding Index (mBI)
It will be measured at 3,6 and 12 months post-operatively. Clinical signs and symptoms of inflammation of peri-implant mucosa will be graded using criteria of modified sulcus bleeding index (mBI).
Measured: 12 months
Peri-implant probing depth
Depth of the peri-implant sulcus will be recorded initially at the time of loading, 3, 6 and 12 months following implant loading by a graduated periodontal probe with light force to avoid undue tissue damage and over-extension into the healthy tissue
Measured: 12 months
Marginal Bone Loss
For the calculation of marginal bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional and panoramic long axis in the center of the implant and bisecting it
Measured: 12 months
Bone Density Recordings
Relative bone density records will be collected from the bucco-palatal view of the cross-sectional plane using the greyscale bone measuring tool
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start30 May 2023
- Primary completion30 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImplantStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Galal, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770231
- Sponsor's protocol ID
- A03012024OS
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Two groups one single drill and undersized groups with 12 months follow up
Publications
Sadek MAG, Amer MZ, El-Gohary N, Elsheikh HA. Peri-implant bone behavior after single drilling technique versus undersized drilling technique of immediately loaded implant in posterior maxilla: a one-year prospective study. BMC Oral Health. 2025 Jun 21;25(1):956. doi: 10.1186/s12903-025-06360-0.
PubMed 40544298
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Bone Behavior After Single Drilling Technique Versus Undersized Technique of Immediately Loaded Implant in Posterior Maxilla: A One-year Prospective Study
- ClinicalTrials.gov ID
- NCT06770231
- Acronym / sponsor ID
- A03012024OS
- Conditions
- Implant
- Keywords
- Implant stability, Immediate loading, Single drilling technique, Posterior maxilla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Jan 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.
Two different drilling techniques in posterior maxilla immediate loading implant
Detailed description
One of the surgical techniques used to enhance the primary stability of implant in low density bone was the undersized drilling technique, which has been introduced to locally optimize poor density of bone by using a final drill diameter considerably smaller compared with the implant diameter.
On the other hand, a novel hollow drill with a single drilling systems was designed. Single drilling technique shortens surgical times, removes the smallest amount of bone during implant site preparation, reduces bone damage and micro fractures, and speeds up the healing process. Additionally, because of the hollow shape, bone core may be harvested and used as an autogenous bone grafting material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Undersized technique | Experimental | Other: Single drill systemNew drilling tech |
| Single drill technique | Active comparator | Other: Single drill systemOne drill system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with missing single or multiple teeth in posterior maxilla.
- Age more than 18 years.
- 10 mm or more vertical bone height is present.
- Good oral hygiene.
- Patients willing to be present during the study follow up intervals.
Key exclusion criteria (5 listed)
- Patients with any pathological lesion or root tips at the planned surgical site.
- Patients with inadequate bone height and thickness.
- Smoking more than 14 cigarettes per day.14
- Alcohol or drug abuse.
- Patients with systemic diseases that absolutely contraindicate implant placement.
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 |
|---|---|---|
| Single drill systemNew system for drilling | Other | Single drill technique, Undersized technique |
Primary outcome
Implant stability
Time frame: 12 months
Implant stability will be assessed at the time of implant insertion and at 3, 6 and 12 months after surgery.
Modified Sulcus Bleeding Index (mBI)
Time frame: 12 months
It will be measured at 3,6 and 12 months post-operatively. Clinical signs and symptoms of inflammation of peri-implant mucosa will be graded using criteria of modified sulcus bleeding index (mBI).
Peri-implant probing depth
Time frame: 12 months
Depth of the peri-implant sulcus will be recorded initially at the time of loading, 3, 6 and 12 months following implant loading by a graduated periodontal probe with light force to avoid undue tissue damage and over-extension into the healthy tissue
Marginal Bone Loss
Time frame: 12 months
For the calculation of marginal bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional and panoramic long axis in the center of the implant and bisecting it
Bone Density Recordings
Time frame: 12 months
Relative bone density records will be collected from the bucco-palatal view of the cross-sectional plane using the greyscale bone measuring tool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 40544298Sadek MAG, Amer MZ, El-Gohary N, Elsheikh HA. Peri-implant bone behavior after single drilling technique versus undersized drilling technique of immediately loaded implant in posterior maxilla: a one-year prospective study. BMC Oral Health. 2025 Jun 21;25(1):956. doi: 10.1186/s12903-025-06360-0.
- Individual participant dataSharing planned: Yes. Two groups one single drill and undersized groups with 12 months follow up
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single drill system in people with Implant, run by Mansoura 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 9 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: finished, as of the sponsor's last update on 13 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant stability (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770231, which also lists 1 linked publication.
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 Jan 2025.