Implant Site ReactionNCT06254885
Insertion Protocol of Convergent Transmucosal Design Implants
A study testing Equi-crestal Implant placement and Sub-crestal Implant placement in people with Implant Site Reaction, run by University of Cagliari at 1 site in Italy.
Trial summary
The aim of this randomized clinical study is the evaluation of the peri-implant mucosal tissues and the marginal bone level, after positioning the transition shoulder from the intraosseous to the transmucosal portion, with an equicrestal position (at the level of the bone crest) or subcrestal (under the bone crest… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- Equi-crestal Implant placement and Sub-crestal Implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2024to 30 Jun 2025
- 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
- Age >18 years
- Absence of periodontal disease
- Full mouth plaque score and full mouth bleeding score less than or equal to 25%
- Sufficient bone height and width to place an implant in a prosthetically guided position without performing bone grafting procedures
- Stable occlusion
Who cannot join
- Smokers (more than 10 cigarettes a day)
- Medical conditions that contraindicate implant surgery
- Pregnant and breastfeeding patients
- Patients with a history of therapy with bisphosphonates or biologics
- Patients undergoing chemotherapy or radiation therapy of the head and neck
- Decompensated diabetes
- Severe bruxism
- Poor oral hygiene or uncooperative patients (incomplete data collection or failure to attend scheduled check-up appointments)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Duilio Casula, AOU Cagliari
Monserrato, CA, 09042
Nicola Alberto Valente, DDS, MS, PHD, navalentedds@gmail.com
Nicola Alberto Valente, DDS, MS, PHD
About this study
Official title: Clinical and Radiographic Evaluation of Equicrestal and Subcrestal Positioning of a Tissue Level Implant With Convergent Transmucosal Profile - Randomized Clinical Trial
The aim of this randomized clinical study is the evaluation of the peri-implant mucosal tissues and the marginal bone level, after positioning the transition shoulder from the intraosseous to the transmucosal portion, with an equicrestal position (at the level of the bone crest) or subcrestal (under the bone crest level).
Read the detailed description
The primary outcomes will be the measurement of the marginal bone level (MBL) at various time intervals and the evaluation of the soft tissues according to a score defined as Pink Esthetic Score (PES). Secondary outcomes will be plaque index (PI); the bleeding index (BI), biological complications (peri-implant mucositis, peri-implantitis, abscesses), implant failure, prosthetic complications (chipping, fractures) and prosthetic failure.
The subjects recruited for the study will be those belonging to the oral surgery department of the San Giovanni di Dio Hospital in Cagliari.
Each patient will receive only one implant or, in any case, only one implant per patient will be included in the analysis. A random sequence will be generated via Randomization.com, useful for assigning patients into the equicrestal and subcrestal implant placement groups.
All patients will undergo the same preoperative, intraoperative and postoperative procedures.
Preoperative procedures An intraoral radiograph of the edentulous site will be performed. Upper and lower alginate impressions will be made on each patient for planning and fabrication of surgical guides, all patients will receive rigorous oral hygiene and instructions will be provided to improve and maintain home oral hygiene.
Intraoperative procedures After local anesthesia of the site to be operated on, a full thickness mucoperiosteal flap will be elevated, after lifting the flap the implant site will be prepared according to the manufacturer's protocol. Before implant placement, the sealed envelope will be opened for random assignment of the patient to one of the two groups. The implant will therefore be positioned, depending on the assignment group, in an equicrestal or subcrestal position, in the latter case a further step with the last preparation drill will be performed to deepen the site.
The flap will be sutured after placement of the healing screw and specific hygiene instructions for the healing site will be given to the patient. The appropriate analgesic and antibiotic therapy will be prescribed.
An intraoral x-ray will be performed in a standardized and repeatable manner to assess bone levels.
The patient will be followed following the following follow-up scheme, reserving the right to recall the patients involved even at longer time intervals to evaluate the aforementioned outcomes also in the medium (24 months) and long (5-10 years) term.
- week: healing check
- weeks: healing check and suture removal
1 month: healing check 3 months: prosthesis and intraoral x-ray, measurement of soft tissue parameters via PES after positioning of the prosthetic crown 6 months: intraoral x-ray and PES 12 months: intraoral x-ray and PES The marginal bone level will be measured using ImageJ software (NIH freeware) on the distal and mesial aspects of each implant at each time point where it is foreseen.
- Conditions
- Implant Site Reaction
- Being tested
- Equi-crestal Implant placement, Sub-crestal Implant placement
- Keywords
- Peri-implant mucosa, Peri-implant bone, Transmucosal profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equi-crestal Implant placementProcedure or surgery
A site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is exactly at the same level as the bone of the maxillary/mandibular edentulous crest.
Sub-crestal Implant placementProcedure or surgery
A site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is 1mm below the level of the bone crest.
| Study group | Role | What they receive |
|---|---|---|
| Sub-crestal | Experimental | Implants will be placed 1mm under the bone crest level Receives: Procedure: Sub-crestal Implant placement |
| Equi-crestal | Active comparator | Implants will be placed at the bone crest level Receives: Procedure: Equi-crestal Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant mucosa health and condition in terms of Pink Esthetic Score (PES).
The PES (Pink Esthetic Score) is a score that evaluates the appearance of the peri-implant soft tissues which examines various parameters giving a value from 0 (worst) to 2 (best) each. (1. the presence/absence of the interproximal papilla both mesial and distal (0=absent, 2=complete); 2. the festooning of the gingival margin in correspondence with the implant (0=unnatural, 2=natural); 3. the position of the gingival margin (0=major discrepancy from reference tooth, 2=no discrepancy); 4. the color of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 5. the appearance (texture) of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 6. defects of the alveolar process (0=obvious deficiency, 2=no deficiency)).
Measured: 6-12 months
Peri-implant mucosa health and condition in terms of Plaque Index (PI).
The Plaque Index (PI) will be calculated. A value of 0 will be assigned if supragingival plaque is not visible, a value of 1 if visible.
Measured: 6-12 months
Peri-implant mucosa health and condition in terms of Bleeding Index (BI)
The Bleeding Index will be calculated on the sites where the periodontal probing will be carried out, a procedure for measuring the depth of the gingival sulcus on 6 sites per tooth (mesial, central, distal, both vestibular and lingual) with a periodontal probe. A value of 0 will be given if there is no bleeding and 1 if the site bleeds within 30 seconds
Measured: 6-12 months
Peri-implant bone health and condition in terms of change in marginal bone level (MBL)
The bone around the implant will be radiographically evaluated in terms of possible resorption measured, using ImageJ software (NIH freeware), on the distal and mesial aspect of each implant at each time point where it is foreseen.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start14 Feb 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Alberto Valente, DDS, MS, PhD, University of Cagliari
- Investigators
- Nicola Alberto Valente, DDS, MS, PhD, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254885
- Sponsor's protocol ID
- PramaNAV
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 16 Feb 2024
- 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 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Equicrestal and Subcrestal Positioning of a Tissue Level Implant With Convergent Transmucosal Profile - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06254885
- Acronym / sponsor ID
- PramaNAV
- Conditions
- Implant Site Reaction
- Keywords
- Peri-implant mucosa, Peri-implant bone, Transmucosal profile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 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 this randomized clinical study is the evaluation of the peri-implant mucosal tissues and the marginal bone level, after positioning the transition shoulder from the intraosseous to the transmucosal portion, with an equicrestal position (at the level of the bone crest) or subcrestal (under the bone crest level).
Detailed description
The primary outcomes will be the measurement of the marginal bone level (MBL) at various time intervals and the evaluation of the soft tissues according to a score defined as Pink Esthetic Score (PES). Secondary outcomes will be plaque index (PI); the bleeding index (BI), biological complications (peri-implant mucositis, peri-implantitis, abscesses), implant failure, prosthetic complications (chipping, fractures) and prosthetic failure.
The subjects recruited for the study will be those belonging to the oral surgery department of the San Giovanni di Dio Hospital in Cagliari.
Each patient will receive only one implant or, in any case, only one implant per patient will be included in the analysis. A random sequence will be generated via Randomization.com, useful for assigning patients into the equicrestal and subcrestal implant placement groups.
All patients will undergo the same preoperative, intraoperative and postoperative procedures.
Preoperative procedures An intraoral radiograph of the edentulous site will be performed. Upper and lower alginate impressions will be made on each patient for planning and fabrication of surgical guides, all patients will receive rigorous oral hygiene and instructions will be provided to improve and maintain home oral hygiene.
Intraoperative procedures After local anesthesia of the site to be operated on, a full thickness mucoperiosteal flap will be elevated, after lifting the flap the implant site will be prepared according to the manufacturer's protocol. Before implant placement, the sealed envelope will be opened for random assignment of the patient to one of the two groups. The implant will therefore be positioned, depending on the assignment group, in an equicrestal or subcrestal position, in the latter case a further step with the last preparation drill will be performed to deepen the site.
The flap will be sutured after placement of the healing screw and specific hygiene instructions for the healing site will be given to the patient. The appropriate analgesic and antibiotic therapy will be prescribed.
An intraoral x-ray will be performed in a standardized and repeatable manner to assess bone levels.
The patient will be followed following the following follow-up scheme, reserving the right to recall the patients involved even at longer time intervals to evaluate the aforementioned outcomes also in the medium (24 months) and long (5-10 years) term.
- week: healing check
- weeks: healing check and suture removal
1 month: healing check 3 months: prosthesis and intraoral x-ray, measurement of soft tissue parameters via PES after positioning of the prosthetic crown 6 months: intraoral x-ray and PES 12 months: intraoral x-ray and PES The marginal bone level will be measured using ImageJ software (NIH freeware) on the distal and mesial aspects of each implant at each time point where it is foreseen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Sub-crestal | Experimental | Procedure: Sub-crestal Implant placementImplants will be placed 1mm under the bone crest level |
| Equi-crestal | Active comparator | Procedure: Equi-crestal Implant placementImplants will be placed at the bone crest level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Absence of periodontal disease
- Full mouth plaque score and full mouth bleeding score less than or equal to 25%
- Sufficient bone height and width to place an implant in a prosthetically guided position without performing bone grafting procedures
- Stable occlusion
Key exclusion criteria (8 listed)
- Smokers (more than 10 cigarettes a day)
- Medical conditions that contraindicate implant surgery
- Pregnant and breastfeeding patients
- Patients with a history of therapy with bisphosphonates or biologics
- Patients undergoing chemotherapy or radiation therapy of the head and neck
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 |
|---|---|---|
| Equi-crestal Implant placementA site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is exactly at the same level as the bone of the maxillary/mandibular edentulous crest. | Procedure or surgery | Equi-crestal |
| Sub-crestal Implant placementA site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is 1mm below the level of the bone crest. | Procedure or surgery | Sub-crestal |
Primary outcome
Peri-implant mucosa health and condition in terms of Pink Esthetic Score (PES).
Time frame: 6-12 months
The PES (Pink Esthetic Score) is a score that evaluates the appearance of the peri-implant soft tissues which examines various parameters giving a value from 0 (worst) to 2 (best) each. (1. the presence/absence of the interproximal papilla both mesial and distal (0=absent, 2=complete); 2. the festooning of the gingival margin in correspondence with the implant (0=unnatural, 2=natural); 3. the position of the gingival margin (0=major discrepancy from reference tooth, 2=no discrepancy); 4. the color of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 5. the appearance (texture) of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 6. defects of the alveolar process (0=obvious deficiency, 2=no deficiency)).
Peri-implant mucosa health and condition in terms of Plaque Index (PI).
Time frame: 6-12 months
The Plaque Index (PI) will be calculated. A value of 0 will be assigned if supragingival plaque is not visible, a value of 1 if visible.
Peri-implant mucosa health and condition in terms of Bleeding Index (BI)
Time frame: 6-12 months
The Bleeding Index will be calculated on the sites where the periodontal probing will be carried out, a procedure for measuring the depth of the gingival sulcus on 6 sites per tooth (mesial, central, distal, both vestibular and lingual) with a periodontal probe. A value of 0 will be given if there is no bleeding and 1 if the site bleeds within 30 seconds
Peri-implant bone health and condition in terms of change in marginal bone level (MBL)
Time frame: 6-12 months
The bone around the implant will be radiographically evaluated in terms of possible resorption measured, using ImageJ software (NIH freeware), on the distal and mesial aspect of each implant at each time point where it is foreseen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
Nicola Alberto Valente, DDS, MS, PhD principal investigator
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equi-crestal Implant placement and Sub-crestal Implant placement in people with Implant Site Reaction, run by University of Cagliari 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 5 inclusion and 8 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 16 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Alberto Valente, DDS, MS, PhD (+393385932069, nicola.valente@unica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant mucosa health and condition in terms of Pink Esthetic Score (PES). (time frame: 6-12 months). The study lists 4 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 16 Feb 2024.