Dental ImplantNCT06250621
Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants. A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability
A study testing Implant placement in people with Dental Implant and Marginal Bone Loss, run by ASST Santi Paolo e Carlo at 1 site in Italy.
Trial summary
The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique, manual or digitally guided, on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Implant, Marginal Bone Loss, Peri Implant Health
- What is being tested?
- Implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2020to 20 Oct 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- absence of mandibular and/or maxillary atrophy; presence of partial edentulism of at least one pair of elements and adequate amount of bone tissue to be able to insert an implant, i.e., a minimum amount of residual bone of 5 mm in thickness and 10 mm in height; presence of an antagonistic element with respect to the tooth to be rehabilitated.
Who cannot join
- patients presenting with a clinical history of systemic diseases and metabolic deficits, presence or previous leukocyte dysfunction/deficiency, blood disorders, hemophilia, dicoumarolic drug therapy, treatment of prolonged steroid therapy, history of neoplasms resulting in chemotherapy and/or radiation therapy in the head and neck district, history of chronic renal problems, chronic liver disease, bone metabolism disorders, uncontrolled endocrine disorders, and ongoing pregnancy and/or lactation. presence of local inflammation such as untreated periodontitis, bruxism condition or clenching habit, habitual oral infections, mucosal disorders (erosive lichen planus), oral lesions (ulcers, malignant lesions), inadequate oral hygiene, and poor compliance.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique, manual or digitally guided, on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally.
Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns. Marginal bone level (MBL) measured at prosthesis installation (t0) at 1 (t1), 2 (t2) and at 3 years of follow-up visit (t3) were considered. MBL change from t0 to t3 was investigated. The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss. Two groups were considered: Test Group (GD) for implant sites treated with a digitally guided surgery procedure. Control Group (FH) for implants surgically placed without digitally guided surgery, respectively. All the procedures were performed by an experienced operator. Additionally, for both groups MBL changes were correlated to different supra-crestal soft tissue height (STH) amounts: less than 3 and ≥ 3 millimeters, respectively. Peri-implant soft tissue parameters such as probing depth (PPD), modified Sulcus Bleeding Index (mBI) and modified Plaque Index (mPI), were assessed for all the restorations included.
- Being tested
- Implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placementProcedure or surgery
Implants were placed by means of a template for a guided surgery approach (GD Group) or with a standard free-hand surgical approach without any additional device (FH Group). A non expert doctor (less that 20 implants placed in the professional activity) was selected for the procedures related to the GD Group; a skilled operator (more than 1000 implants placed in the professional activity) was selected for the procedures related to the FH Group, respectively.
A two-stage surgical technique was chosen. Implants were placed (Anyridge, Megagen Implants, Seoul, Korea) 1 mm below the crestal level, as recommended by the manufacturer. After flap elevation the height of the supra-crestal soft tissue (STH) was measured by means of a calibrated probe.
An inter-implant distance of 3 mm at least, and/or an interproximal space from 1.5 to 3 mm between an implant and the adjacent tooth were observed.
Flaps were sutured over the implants to allow a submerged healing.
| Study group | Role | What they receive |
|---|---|---|
| Test Group (GD) | Experimental | in this group were considered implant sites treated with a digitally guided surgery procedure Receives: Procedure: Implant placement |
| Control Group (FH) | Active comparator | in this group were considered implant sites treated without a digitally guided surgery procedure Receives: Procedure: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Measurements were made at mesial and distal aspect of each implant and were reported in millimeters.
Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values.
Measurements were made at mesial and distal aspect of each implant and were reported in millimeters.
Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values.
Measured: From t0 to t3 (3-years of follow up)
Secondary outcomes (1)
STH
After flap elevation the height of the supra-crestal soft tissue (STH) was measured by means of a calibrated probe.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start10 Jan 2020
- Primary completion15 May 2021
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Santi Paolo e Carlo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenio ER Romeo, Prof., Study director, Odontostomatologia I, ASST Santi Paolo e Carlo, P.O. S. Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250621
- Sponsor's protocol ID
- EC 1564/18
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants. A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability
- ClinicalTrials.gov ID
- NCT06250621
- Acronym / sponsor ID
- EC 1564/18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ASST Santi Paolo e CarloUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 9 Feb 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.
The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique, manual or digitally guided, on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally.
Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns. Marginal bone level (MBL) measured at prosthesis installation (t0) at 1 (t1), 2 (t2) and at 3 years of follow-up visit (t3) were considered. MBL change from t0 to t3 was investigated. The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss. Two groups were considered: Test Group (GD) for implant sites treated with a digitally guided surgery procedure. Control Group (FH) for implants surgically placed without digitally guided surgery, respectively. All the procedures were performed by an experienced operator. Additionally, for both groups MBL changes were correlated to different supra-crestal soft tissue height (STH) amounts: less than 3 and ≥ 3 millimeters, respectively. Peri-implant soft tissue parameters such as probing depth (PPD), modified Sulcus Bleeding Index (mBI) and modified Plaque Index (mPI), were assessed for all the restorations included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group (GD) | Experimental | Procedure: Implant placementin this group were considered implant sites treated with a digitally guided surgery procedure |
| Control Group (FH) | Active comparator | Procedure: Implant placementin this group were considered implant sites treated without a digitally guided surgery procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- absence of mandibular and/or maxillary atrophy; presence of partial edentulism of at least one pair of elements and adequate amount of bone tissue to be able to insert an implant, i.e., a minimum amount of residual bone of 5 mm in thickness and 10 mm in height; presence of an antagonistic element with respect to the tooth to be rehabilitated.
Key exclusion criteria (1 listed)
- patients presenting with a clinical history of systemic diseases and metabolic deficits, presence or previous leukocyte dysfunction/deficiency, blood disorders, hemophilia, dicoumarolic drug therapy, treatment of prolonged steroid therapy, history of neoplasms resulting in chemotherapy and/or radiation therapy in the head and neck district, history of chronic renal problems, chronic liver disease, bone metabolism disorders, uncontrolled endocrine disorders, and ongoing pregnancy and/or lactation. presence of local inflammation such as untreated periodontitis, bruxism condition or clenching habit, habitual oral infections, mucosal disorders (erosive lichen planus), oral lesions (ulcers, malignant lesions), inadequate oral hygiene, and poor compliance.
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 |
|---|---|---|
| Implant placementImplants were placed by means of a template for a guided surgery approach (GD Group) or with a standard free-hand surgical approach without any additional device (FH Group). A non expert doctor (less that 20 implants placed in the professional activity) was selected for the procedures related to the GD Group; a skilled operator (more than 1000 implants placed in the professional activity) was selected for the procedures related to the FH Group, respectively. A two-stage surgical technique was chosen. Implants were placed (Anyridge, Megagen Implants, Seoul, Korea) 1 mm below the crestal level, as recommended by the manufacturer. After flap elevation the height of the supra-crestal soft tissue (STH) was measured by means of a calibrated probe. An inter-implant distance of 3 mm at least, and/or an interproximal space from 1.5 to 3 mm between an implant and the adjacent tooth were observed. Flaps were sutured over the implants to allow a submerged healing. | Procedure or surgery | Control Group (FH), Test Group (GD) |
Primary outcome
Marginal bone loss
Time frame: From t0 to t3 (3-years of follow up)
Measurements were made at mesial and distal aspect of each implant and were reported in millimeters. Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values. Measurements were made at mesial and distal aspect of each implant and were reported in millimeters. Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values.
1 secondary outcome
STH
Time frame: During surgery
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 9 Feb 2024.
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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.
Eugenio ER Romeo, Prof. study director
Odontostomatologia I, ASST Santi Paolo e Carlo, P.O. S. Paolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement in people with Dental Implant and Marginal Bone Loss, run by ASST Santi Paolo e Carlo at 1 site in Italy.
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 1 inclusion and 1 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 9 Feb 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 Italy. 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?
Marginal bone loss (time frame: From t0 to t3 (3-years of follow up)). 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 9 Feb 2024.