Dental ImplantNCT05670340
Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants
A study testing Switched Prosthetic Profile and Matched Prosthetic Profile in people with Dental Implant and Soft Tissue, run by University of Salamanca at 1 site in Spain.
Trial summary
In this clinical trial the effect of the implant-abutment morphology (platform-switched vs platform matched) will be assessed in both soft tissue (soft tissue thickness) and hard tissue (marginal bone loss) outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Soft Tissue, Partial-edentulism
- What is being tested?
- Switched Prosthetic Profile and Matched Prosthetic Profile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2020to 1 Feb 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 of legal age (>18 years).
- With rehabilitation needs with 1 maxillary or mandibular implant in mature bone (more than 4 months after tooth extraction) in the posterior sector (premolars and molars).
- With good hygiene (plaque and gingival index ≤ 25%).
Who cannot join
- Medical conditions that contraindicated implant surgery.
- Patients with immunological alterations, pregnant and lactating.
- Heavy smokers > 20 cigarettes/day,
- Requiring bone augmentations or of soft tissues.
- Patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screw-retained restorations.
Trial locations and contacts
1 site in 1 country.
About this study
In this clinical trial the effect of the implant-abutment morphology (platform-switched vs platform matched) will be assessed in both soft tissue (soft tissue thickness) and hard tissue (marginal bone loss) outcomes. Several clinical predictors (initial implant position level, gingival biotype, abutment height and prosthetic emergence profile) will also be taken into account as modulating factors of the clinical outcome.
Read the detailed description
This prospective clinical trial is conducted at the Dental Clinic of the Faculty of Medicine of the University of Salamanca. The protocol was developed in accordance with the 1975 Declaration of Helsinki, and later approved by the Bioethics Committee of the University of Salamanca with the number (Ref:473/2020)
Before initiating any procedure, each patient received information about the study design and signed an informed consent. The subjects are recruited consecutively following the admission protocols of the Dental Clinic of the Faculty of Medicine of the University of Salamanca, Salamanca, Spain. The inclusion criteria are:
(1) Patients of legal age (>18 years); (2) in need of at least one maxillary or mandibular dental implant to be inserted in mature bone (more than 4 months after tooth extraction) in the posterior area (premolars and molars); (3) with good oral hygiene (plaque and gingival index ≤ 25%). The exclusion criteria included clinical conditions that contraindicated implant surgery, (1) patients with immunological alterations, pregnant and lactating, (2) heavy smokers > 20 cigarettes/day, (3) with the need for bone or soft tissue augmentations, (4) patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screwed restorations.
All implants were placed by an experienced implantologist following standard procedures and the manufacturer's recommendations. All implants were connected to a transmucosal abutment to heal in one-stage approach. Several variables were collected in this surgical phase (bone quality, implant stability, implant-bone level, mucosal thickness, keratinized mucosa width ...)
After 3 to 4 months of implant healing all the clinical parameters were reevaluated and the final impression will be used for the manufacturing of a porcelain-fused to metal screwed crowns.
Two types of data will be analyzed: Cross-sectional and longitudinal data. On the one hand, cross-sectional data included sociodemographic (sex and age), behavioral (smoking, oral hygiene..) clinical (antagonist, adjacent dentition, arch location, implant diameter and length, insertion torque values, bone density, implant-level...) and prosthetics (abutment and prosthetic profiles, interocclusal prosthetic space, cantilever lengths...).
On the other hand, the longitudinal variables were classified into 2 types, related to the gingival tissues and related to the surrounding bone. Regarding the gingival tissues these were the longitudinal variables assessed in different follow-up observations (at 3, 6 and 12 months): plaque and gingival index, keratinized mucosa width. Regarding the bone-related variables the implant stability by ISQ as well as the marginal bone position were also measured at 3, 6 and 12 months.
- Conditions
- Dental Implant, Soft Tissue, Partial-edentulism, Bone Loss
- Being tested
- Switched Prosthetic Profile, Matched Prosthetic Profile
- Keywords
- dental implant, marginal bone loss, peri-implant soft tissue, ISQ
- 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.
Switched Prosthetic ProfileDevice
The implant will be rehabilitated with a switched emergence profile
Matched Prosthetic ProfileDevice
The implant will be rehabilitated with a matched emergence profile
| Study group | Role | What they receive |
|---|---|---|
| Swithed-platform | Experimental | In this group the implants will be rehabilitated with a narrower emergence profile for the prosthetic rehabilitation. Receives: Device: Switched Prosthetic Profile |
| Matched-platform | Active comparator | This the conventional approach in wich the prosthetic rehabilitation is matched with the implant-platform dimensions Receives: Device: Matched Prosthetic Profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Peri-implant Marginal Bone level
The implant-bone level is assesssed radiographicly
Measured: At baseline (reference), in comparison with 3, 6 and 12 months
Change in the Implant stablity quotient
The ISQ is assesssed by Osstell
Measured: At baseline (reference), and in comparison with the 3 months follow-up
Change in the Gingival Thickness
The gingival thickness will be assessed by measuring the keratinized region around implants with a periodontal probe and a thickness caliper
Measured: At baseline (reference) and in comparison with the 3, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start22 Jan 2020
- Primary completion20 May 2023
- Study completion1 Feb 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The implant abutment height could be short (\<2mm) or long (\>2mm)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670340
- Sponsor's protocol ID
- Usal_2020_433
- Status last verified
- May 2024
- First submitted
- 29 Nov 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quispe-Lopez N, Guadilla Y, Gomez-Polo C, Lopez-Valverde N, Flores-Fraile J, Montero J. The influence of implant depth, abutment height and mucosal phenotype on peri-implant bone levels: A 2-year clinical trial. J Dent. 2024 Sep;148:105264. doi: 10.1016/j.jdent.2024.105264. Epub 2024 Jul 23.
PubMed 39053878
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants
- ClinicalTrials.gov ID
- NCT05670340
- Acronym / sponsor ID
- Usal_2020_433
- Conditions
- Dental Implant, Soft Tissue, Partial-edentulism, Bone Loss
- Keywords
- dental implant, marginal bone loss, peri-implant soft tissue, ISQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 4 Jan 2023 (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.
In this clinical trial the effect of the implant-abutment morphology (platform-switched vs platform matched) will be assessed in both soft tissue (soft tissue thickness) and hard tissue (marginal bone loss) outcomes. Several clinical predictors (initial implant position level, gingival biotype, abutment height and prosthetic emergence profile) will also be taken into account as modulating factors of the clinical outcome.
Detailed description
This prospective clinical trial is conducted at the Dental Clinic of the Faculty of Medicine of the University of Salamanca. The protocol was developed in accordance with the 1975 Declaration of Helsinki, and later approved by the Bioethics Committee of the University of Salamanca with the number (Ref:473/2020)
Before initiating any procedure, each patient received information about the study design and signed an informed consent. The subjects are recruited consecutively following the admission protocols of the Dental Clinic of the Faculty of Medicine of the University of Salamanca, Salamanca, Spain. The inclusion criteria are:
(1) Patients of legal age (>18 years); (2) in need of at least one maxillary or mandibular dental implant to be inserted in mature bone (more than 4 months after tooth extraction) in the posterior area (premolars and molars); (3) with good oral hygiene (plaque and gingival index ≤ 25%). The exclusion criteria included clinical conditions that contraindicated implant surgery, (1) patients with immunological alterations, pregnant and lactating, (2) heavy smokers > 20 cigarettes/day, (3) with the need for bone or soft tissue augmentations, (4) patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screwed restorations.
All implants were placed by an experienced implantologist following standard procedures and the manufacturer's recommendations. All implants were connected to a transmucosal abutment to heal in one-stage approach. Several variables were collected in this surgical phase (bone quality, implant stability, implant-bone level, mucosal thickness, keratinized mucosa width ...)
After 3 to 4 months of implant healing all the clinical parameters were reevaluated and the final impression will be used for the manufacturing of a porcelain-fused to metal screwed crowns.
Two types of data will be analyzed: Cross-sectional and longitudinal data. On the one hand, cross-sectional data included sociodemographic (sex and age), behavioral (smoking, oral hygiene..) clinical (antagonist, adjacent dentition, arch location, implant diameter and length, insertion torque values, bone density, implant-level...) and prosthetics (abutment and prosthetic profiles, interocclusal prosthetic space, cantilever lengths...).
On the other hand, the longitudinal variables were classified into 2 types, related to the gingival tissues and related to the surrounding bone. Regarding the gingival tissues these were the longitudinal variables assessed in different follow-up observations (at 3, 6 and 12 months): plaque and gingival index, keratinized mucosa width. Regarding the bone-related variables the implant stability by ISQ as well as the marginal bone position were also measured at 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The implant abutment height could be short (<2mm) or long (>2mm)
| Arm | Type | Receives |
|---|---|---|
| Swithed-platform | Experimental | Device: Switched Prosthetic ProfileIn this group the implants will be rehabilitated with a narrower emergence profile for the prosthetic rehabilitation. |
| Matched-platform | Active comparator | Device: Matched Prosthetic ProfileThis the conventional approach in wich the prosthetic rehabilitation is matched with the implant-platform dimensions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of legal age (>18 years).
- With rehabilitation needs with 1 maxillary or mandibular implant in mature bone (more than 4 months after tooth extraction) in the posterior sector (premolars and molars).
- With good hygiene (plaque and gingival index ≤ 25%).
Key exclusion criteria (5 listed)
- Medical conditions that contraindicated implant surgery.
- Patients with immunological alterations, pregnant and lactating.
- Heavy smokers > 20 cigarettes/day,
- Requiring bone augmentations or of soft tissues.
- Patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screw-retained restorations.
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 |
|---|---|---|
| Switched Prosthetic ProfileThe implant will be rehabilitated with a switched emergence profile | Device | Swithed-platform |
| Matched Prosthetic ProfileThe implant will be rehabilitated with a matched emergence profile | Device | Matched-platform |
Primary outcome
Change in the Peri-implant Marginal Bone level
Time frame: At baseline (reference), in comparison with 3, 6 and 12 months
The implant-bone level is assesssed radiographicly
Change in the Implant stablity quotient
Time frame: At baseline (reference), and in comparison with the 3 months follow-up
The ISQ is assesssed by Osstell
Change in the Gingival Thickness
Time frame: At baseline (reference) and in comparison with the 3, 6 and 12 months follow-up
The gingival thickness will be assessed by measuring the keratinized region around implants with a periodontal probe and a thickness caliper
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 16 May 2024.
- Derived from this study: PubMed 39053878Quispe-Lopez N, Guadilla Y, Gomez-Polo C, Lopez-Valverde N, Flores-Fraile J, Montero J. The influence of implant depth, abutment height and mucosal phenotype on peri-implant bone levels: A 2-year clinical trial. J Dent. 2024 Sep;148:105264. doi: 10.1016/j.jdent.2024.105264. Epub 2024 Jul 23.
- Individual participant dataSharing planned: No
Related trials for Dental Implant
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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 Switched Prosthetic Profile and Matched Prosthetic Profile in people with Dental Implant and Soft Tissue, run by University of Salamanca 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 3 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 16 May 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 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.
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?
Change in the Peri-implant Marginal Bone level (time frame: At baseline (reference), in comparison with 3, 6 and 12 months). The study lists 3 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 NCT05670340, 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 16 May 2024.