MBLPhase 3NCT06780956
Simplified vs Conventional Drilling Protocol for Implant Placment
A Phase 3 study testing Conventional and simplfied in people with MBL and Bone Loss, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Despite the growing interest in these alternative drilling protocols, there is a lack of robust clinical evidence evaluating their long-term effects on MBL. The aim of the present study was therefore, to evaluate the effect of implant site preparation technique (conventional drilling versus simplfied) on change in the… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Conventional and simplfied
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to 1 Mar 2024
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients without any systemic pathologies that could be considered grounds for absolute contraindication.
- Adult patients who agreed to participate in the study and signed the informed consent form.
- Patients who smoked fewer than ten cigarettes per day.
- Patients who were not completely edentulous.
- Patients who were partially edentulous in the posterior maxillary or mandibular area and did not require the use of regenerative techniques.
- Patients with an area of healed, mature bone at least three months post-extraction.
Who cannot join
- Patients missing teeth in the esthetic zones 13-23 and 33-43 (second and fifth sextants).
- Patients who smoked more than ten cigarettes per day.
- Patients with a bleeding index greater than 30%.
- Patients with dental caries or periodontal disease.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-implant Tissue Stability of Simplified vs Conventional Drilling Protocol Randomized Trial With 24-month Follow-up.
Despite the growing interest in these alternative drilling protocols, there is a lack of robust clinical evidence evaluating their long-term effects on MBL. The aim of the present study was therefore, to evaluate the effect of implant site preparation technique (conventional drilling versus simplfied) on change in the marginal bone level and insertion torque.
- Being tested
- Conventional, simplfied
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalOther
conventional drilling protocol using full sequence
simplfiedOther
3 burrs for implant placment
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | Conventional Drilling Protocol Receives: Other: Conventional |
| simplfied | Experimental | simplfied drilling protocol Receives: Other: simplfied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss (MBL)
Is a non-infective remodeling process of variable entity occurring after implant placement.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Dec 2020
- Primary completion1 Jul 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MBLStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artiom Lijnev, San Antonio Technologies - San Antonio Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780956
- Sponsor's protocol ID
- CE092002
- Status last verified
- Jan 2025
- First submitted
- 24 Oct 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Tissue Stability of Simplified vs Conventional Drilling Protocol Randomized Trial With 24-month Follow-up.
- ClinicalTrials.gov ID
- NCT06780956
- Acronym / sponsor ID
- CE092002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 17 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.
Despite the growing interest in these alternative drilling protocols, there is a lack of robust clinical evidence evaluating their long-term effects on MBL. The aim of the present study was therefore, to evaluate the effect of implant site preparation technique (conventional drilling versus simplfied) on change in the marginal bone level and insertion torque.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | Active comparator | Other: ConventionalConventional Drilling Protocol |
| simplfied | Experimental | Other: simplfiedsimplfied drilling protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients without any systemic pathologies that could be considered grounds for absolute contraindication.
- Adult patients who agreed to participate in the study and signed the informed consent form.
- Patients who smoked fewer than ten cigarettes per day.
- Patients who were not completely edentulous.
- Patients who were partially edentulous in the posterior maxillary or mandibular area and did not require the use of regenerative techniques.
Key exclusion criteria (5 listed)
- Patients missing teeth in the esthetic zones 13-23 and 33-43 (second and fifth sextants).
- Patients who smoked more than ten cigarettes per day.
- Patients with a bleeding index greater than 30%.
- Patients with dental caries or periodontal disease.
- Pregnant or lactating women.
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 |
|---|---|---|
| Conventionalconventional drilling protocol using full sequence | Other | conventional |
| simplfied3 burrs for implant placment | Other | simplfied |
Primary outcome
Marginal bone loss (MBL)
Time frame: 24 month
Is a non-infective remodeling process of variable entity occurring after implant placement.
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 17 Jan 2025.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing Conventional and simplfied in people with MBL and Bone Loss, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 6 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 17 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 Spain. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Marginal bone loss (MBL) (time frame: 24 month). 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 Jan 2025.