Missing TeethNCT06334081
Different Surgical Drilling Protocols in Posterior Maxilla
A study testing undersized drilling technique and single drilling technique in people with Missing Teeth, run by Mansoura University at 1 site in Egypt.
Trial summary
Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- undersized drilling technique and single drilling technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2023to 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 missed one or more posterior maxillary tooth.
- Be older than 18 years and of residual bone height more than10 mm.
- Patients with good oral hygiene and willing to participate in the follow-up sessions.
- Patients with adequate mesio-distal width and inter-arch space.
- Patients without any para-functional habits such as clenching and bruxism.
Who cannot join
- Patients whose proposed surgical site had any pathological lesion or root tips.
- Drug or alcohol abuse.
- Patients with uncontrolled systemic diseases.
- Pregnant patients.
- Tobacco use more than fourteen cigarettes daily.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Two Different Surgical Drilling Protocols of Immediate Loaded Dental Implant in Posterior Maxilla
Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants
Read the detailed description
16 dental implants were inserted in 16 patients were divided into two groups: Group A: 8 dental implants were inserted using undersized drilling technique and Group B: 8 dental implants were inserted using single drilling technique. then the dental implants were assessed for 6 months regarding
Clinical Evalution: regarding these parameters after immediately dental implants loading,3 months and 6 months.
implant stability, implant probing depth, bleeding index.
Radiographic evaluation: immediately after implant loading and 6 months after loading regarding bone density and marginal bone loss.
- Conditions
- Missing Teeth
- Being tested
- undersized drilling technique, single drilling technique
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
undersized drilling techniqueProcedure or surgery
In group A The implant site preparation was made according to the protocol of the manufacturer except that the final drill was omitted. The drilling was done using a low speed reduction, high torque with coolant contra-angle hand piece with surgical motor unit. Speed of drilling was 800-1200 rpm.
single drilling techniqueProcedure or surgery
In group B The implant bed was prepared using the new specially designed drills. First, the use of the guide drill of length 3.5mm with speed of 800 rpm and torque of 35 nm, then the use of the one drill of the same diameter of the selected implant size to the full length of the osteotomy site.
| Study group | Role | What they receive |
|---|---|---|
| Group A dental implant placement by undersized drilling technique. | Experimental | 8 dental implants placed in the healed alveolar posterior maxillary ridge using undersized drilling technique Receives: Procedure: undersized drilling technique |
| Group B dental implant placement by single drilling technique | Experimental | 8 dental implants placed in the healed alveolar posterior maxillary ridge using singledrilling technique Receives: Procedure: single drilling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone density measurement
cbct will be done to evaluate difference in bone density
Measured: 6 month
marginal bone loss
cbct will be done to evaluate marginal bone loss
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start29 Jun 2023
- Primary completion30 Dec 2023
- 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 Missing TeethStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Elsheikh, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334081
- Sponsor's protocol ID
- A02040230S
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Two Different Surgical Drilling Protocols of Immediate Loaded Dental Implant in Posterior Maxilla
- ClinicalTrials.gov ID
- NCT06334081
- Acronym / sponsor ID
- A02040230S
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 Mar 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.
Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants
Detailed description
16 dental implants were inserted in 16 patients were divided into two groups: Group A: 8 dental implants were inserted using undersized drilling technique and Group B: 8 dental implants were inserted using single drilling technique. then the dental implants were assessed for 6 months regarding
Clinical Evalution: regarding these parameters after immediately dental implants loading,3 months and 6 months.
implant stability, implant probing depth, bleeding index.
Radiographic evaluation: immediately after implant loading and 6 months after loading regarding bone density and marginal bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A dental implant placement by undersized drilling technique. | Experimental | Procedure: undersized drilling technique8 dental implants placed in the healed alveolar posterior maxillary ridge using undersized drilling technique |
| Group B dental implant placement by single drilling technique | Experimental | Procedure: single drilling technique8 dental implants placed in the healed alveolar posterior maxillary ridge using singledrilling technique |
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 missed one or more posterior maxillary tooth.
- Be older than 18 years and of residual bone height more than10 mm.
- Patients with good oral hygiene and willing to participate in the follow-up sessions.
- Patients with adequate mesio-distal width and inter-arch space.
- Patients without any para-functional habits such as clenching and bruxism.
Key exclusion criteria (5 listed)
- Patients whose proposed surgical site had any pathological lesion or root tips.
- Drug or alcohol abuse.
- Patients with uncontrolled systemic diseases.
- Pregnant patients.
- Tobacco use more than fourteen cigarettes daily.
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 |
|---|---|---|
| undersized drilling techniqueIn group A The implant site preparation was made according to the protocol of the manufacturer except that the final drill was omitted. The drilling was done using a low speed reduction, high torque with coolant contra-angle hand piece with surgical motor unit. Speed of drilling was 800-1200 rpm. | Procedure or surgery | Group A dental implant placement by undersized drilling technique. |
| single drilling techniqueIn group B The implant bed was prepared using the new specially designed drills. First, the use of the guide drill of length 3.5mm with speed of 800 rpm and torque of 35 nm, then the use of the one drill of the same diameter of the selected implant size to the full length of the osteotomy site. | Procedure or surgery | Group B dental implant placement by single drilling technique |
Primary outcome
bone density measurement
Time frame: 6 month
cbct will be done to evaluate difference in bone density
marginal bone loss
Time frame: 6 month
cbct will be done to evaluate marginal bone loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Related trials for Missing Teeth
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Recruiting
Effect of Changing Grafting Sequences During Sinus Lifting & Simultaneous Implant Placement in the Gained Bone Using Customized Surgical Guide
Vertical Bone Defects, Missing Tooth/Teeth
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 undersized drilling technique and single drilling technique in people with Missing Teeth, 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 5 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 27 Mar 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?
bone density measurement (time frame: 6 month). The study lists 2 primary outcomes in all. 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 27 Mar 2024.