Peri-implant Marginal Bone LossNCT04385355
Influence of the Design of the Transmucosal Abutment on the Periimplant Bone Level
A study testing Conventional transmucosal abutment design and Narrow transmucosal abutment design in people with Peri-implant Marginal Bone Loss and Peri-implant Bone Level, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implant Marginal Bone Loss, Peri-implant Bone Level, Transmucosal Abutment Design
- What is being tested?
- Conventional transmucosal abutment design and Narrow transmucosal abutment design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to 1 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absence of systemic and periodontal pathology, over 18 years of age, with a plaque index below 25%.
- Absence of at least one tooth, with natural adjacent teeth, allowing a prosthetic rehabilitation with an osseointegrated implant and a prosthetic unit.
- Adequate bone quality available, allowing placement of MOZO GRAU® implants InHex STD QUATTRO with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm.
- Natural teeth or implants with fixed restoration as antagonists.
Who cannot join
- Systemic factors:
- Continuous administration of systemic medication that can interfere with the bone metabolism or medical conditions requiring prolonged use of steroids and / or medications that can interfere with bone metabolism.
- History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, kidney failure or bone metabolic disorders, such as osteoporosis.
- Physical disability that may interfere with proper oral hygiene.
- Use of any investigational medication or device within the previous 30 days to implant surgery in the study.
- Alcoholism or drug addiction
Show all 15Show fewer
- Smoker of more than 10 cigarettes per day.
- Conditions or circumstances that could prevent compliance with participation in study or interfere with the analysis of results, such as a history of breach or unreliability.
- Local factors:
- History of local radiotherapy.
- Bruxism.
- Diseases that affect the oral mucosa, such as oral lichen planus.
- Untreated periodontitis.
- Persistent intraoral infection.
- Post-extraction alveoli not cured (less than 6 weeks after extraction).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Santiago de Compostela
Santiago de Compostela, La Coruña, 15782
Lucia Maceiras, +0034676780483, luciamaceiraspombo@outlook.com
About this study
Official title: Influence of the Design of the Transmucosal Abutment on the Marginal Periimplant Bone Loss. Randomized Clinical Trial
The objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height
Read the detailed description
Patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. The control group will receive conventional transmucosal abutments while the test group will receive TCP abutments, with a narrower design.
Results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.
- Conditions
- Peri-implant Marginal Bone Loss, Peri-implant Bone Level, Transmucosal Abutment Design, Peri-implant Bone Loss
- Being tested
- Conventional transmucosal abutment design, Narrow transmucosal abutment design
- Keywords
- periimplant bone loss, abutment design, transmucosal abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional transmucosal abutment designDevice
The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one
Narrow transmucosal abutment designDevice
The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Control group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed. Receives: Device: Conventional transmucosal abutment design |
| Test Group | Experimental | Test group will receive an intermediate transmucosal abutment with a TCP design, narrower than the conventional one, of 3mm height, once the implants are placed Receives: Device: Narrow transmucosal abutment design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic marginal periimplant bone level changes
Measured as the distance from the bone crest to the first implant-to-bone contact. This will be assessed on parallelized periapical radiographies
Measured: from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Secondary outcomes (6)
Probing pocket depth
measured with a CP12 probe as the distance from the soft tissue margin to the bottom of the peri-implant pocket
Measured: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Papilla refill
Evaluated according to the Jemt 1997 index
Measured: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Bleeding on probing
Evaluated according to the Mombelli 1987 index, presence of bleeding after probing
Measured: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Plaque index
Evaluated according to the Mombelli 1987 index, presence of plaque
Measured: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Patient Reported Outcomes Measurements
Using a visual analoge scale from 1 to 10 to evaluate patient's satisfaction parameters related to the aesthetics, masticatory ability, confort, general satisfaction and phonetics
Measured: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Adverse effects frequency
Presence of adverse effects during the follow-up, such as fracture of the implant or the prosthetic unit or presence of periimplantitis or mucositis
Measured: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Oct 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peri-implant Marginal Bone LossStudies 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
- For each participant on the test group will be another participant on the control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Mozo Grau Ticare Implants
- Responsible party
- Principal investigator, Juan Blanco Carrión, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385355
- Sponsor's protocol ID
- ECRMGTCP2020
- Status last verified
- Sep 2021
- First submitted
- 6 May 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alves CC, Munoz F, Cantalapiedra A, Ramos I, Neves M, Blanco J. Marginal bone and soft tissue behavior following platform switching abutment connection/disconnection--a dog model study. Clin Oral Implants Res. 2015 Sep;26(9):983-91. doi: 10.1111/clr.12385. Epub 2014 Apr 16.
PubMed 24735458Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x.
PubMed 8915028Blanco J, Pico A, Caneiro L, Novoa L, Batalla P, Martin-Lancharro P. Effect of abutment height on interproximal implant bone level in the early healing: A randomized clinical trial. Clin Oral Implants Res. 2018 Jan;29(1):108-117. doi: 10.1111/clr.13108. Epub 2017 Dec 8.
PubMed 29222809Ericsson I, Persson LG, Berglundh T, Marinello CP, Lindhe J, Klinge B. Different types of inflammatory reactions in peri-implant soft tissues. J Clin Periodontol. 1995 Mar;22(3):255-61. doi: 10.1111/j.1600-051x.1995.tb00143.x.
PubMed 7790533Koutouzis T, Adeinat B, Ali A. The influence of abutment macro-design on clinical and radiographic peri-implant tissue changes for guided, placed, and restored implants: A 1-year randomized controlled trial. Clin Oral Implants Res. 2019 Sep;30(9):882-891. doi: 10.1111/clr.13493. Epub 2019 Jun 24.
PubMed 31180160Novoa L, Batalla P, Caneiro L, Pico A, Linares A, Blanco J. Influence of Abutment Height on Maintenance of Peri-implant Crestal Bone at Bone-Level Implants: A 3-Year Follow-up Study. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):721-727. doi: 10.11607/prd.2762.
PubMed 28817138Souza AB, Alshihri A, Kammerer PW, Araujo MG, Gallucci GO. Histological and micro-CT analysis of peri-implant soft and hard tissue healing on implants with different healing abutments configurations. Clin Oral Implants Res. 2018 Oct;29(10):1007-1015. doi: 10.1111/clr.13367. Epub 2018 Sep 23.
PubMed 30246409
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Design of the Transmucosal Abutment on the Marginal Periimplant Bone Loss. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04385355
- Acronym / sponsor ID
- ECRMGTCP2020
- Conditions
- Peri-implant Marginal Bone Loss, Peri-implant Bone Level, Transmucosal Abutment Design, Peri-implant Bone Loss
- Keywords
- periimplant bone loss, abutment design, transmucosal abutment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Mozo Grau Ticare Implants
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 12 May 2020 (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 objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height
Detailed description
Patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. The control group will receive conventional transmucosal abutments while the test group will receive TCP abutments, with a narrower design.
Results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- For each participant on the test group will be another participant on the control group
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Device: Conventional transmucosal abutment designControl group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed. |
| Test Group | Experimental | Device: Narrow transmucosal abutment designTest group will receive an intermediate transmucosal abutment with a TCP design, narrower than the conventional one, of 3mm height, once the implants are placed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Absence of systemic and periodontal pathology, over 18 years of age, with a plaque index below 25%.
- Absence of at least one tooth, with natural adjacent teeth, allowing a prosthetic rehabilitation with an osseointegrated implant and a prosthetic unit.
- Adequate bone quality available, allowing placement of MOZO GRAU® implants InHex STD QUATTRO with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm.
- Natural teeth or implants with fixed restoration as antagonists.
Key exclusion criteria (15 listed)
- Systemic factors:
- History of local radiotherapy.
- Bruxism.
- Diseases that affect the oral mucosa, such as oral lichen planus.
- Untreated periodontitis.
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 |
|---|---|---|
| Conventional transmucosal abutment designThe macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one | Device | Control Group |
| Narrow transmucosal abutment designThe macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one | Device | Test Group |
Primary outcome
Radiographic marginal periimplant bone level changes
Time frame: from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Measured as the distance from the bone crest to the first implant-to-bone contact. This will be assessed on parallelized periapical radiographies
6 secondary outcomes
Probing pocket depth
Time frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Papilla refill
Time frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Bleeding on probing
Time frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Plaque index
Time frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Patient Reported Outcomes Measurements
Time frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Adverse effects frequency
Time frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 24735458Alves CC, Munoz F, Cantalapiedra A, Ramos I, Neves M, Blanco J. Marginal bone and soft tissue behavior following platform switching abutment connection/disconnection--a dog model study. Clin Oral Implants Res. 2015 Sep;26(9):983-91. doi: 10.1111/clr.12385. Epub 2014 Apr 16.
- Background: PubMed 8915028Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x.
- Background: PubMed 29222809Blanco J, Pico A, Caneiro L, Novoa L, Batalla P, Martin-Lancharro P. Effect of abutment height on interproximal implant bone level in the early healing: A randomized clinical trial. Clin Oral Implants Res. 2018 Jan;29(1):108-117. doi: 10.1111/clr.13108. Epub 2017 Dec 8.
- Background: PubMed 7790533Ericsson I, Persson LG, Berglundh T, Marinello CP, Lindhe J, Klinge B. Different types of inflammatory reactions in peri-implant soft tissues. J Clin Periodontol. 1995 Mar;22(3):255-61. doi: 10.1111/j.1600-051x.1995.tb00143.x.
- Background: PubMed 31180160Koutouzis T, Adeinat B, Ali A. The influence of abutment macro-design on clinical and radiographic peri-implant tissue changes for guided, placed, and restored implants: A 1-year randomized controlled trial. Clin Oral Implants Res. 2019 Sep;30(9):882-891. doi: 10.1111/clr.13493. Epub 2019 Jun 24.
- Background: PubMed 28817138Novoa L, Batalla P, Caneiro L, Pico A, Linares A, Blanco J. Influence of Abutment Height on Maintenance of Peri-implant Crestal Bone at Bone-Level Implants: A 3-Year Follow-up Study. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):721-727. doi: 10.11607/prd.2762.
- Background: PubMed 30246409Souza AB, Alshihri A, Kammerer PW, Araujo MG, Gallucci GO. Histological and micro-CT analysis of peri-implant soft and hard tissue healing on implants with different healing abutments configurations. Clin Oral Implants Res. 2018 Oct;29(10):1007-1015. doi: 10.1111/clr.13367. Epub 2018 Sep 23.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional transmucosal abutment design and Narrow transmucosal abutment design in people with Peri-implant Marginal Bone Loss and Peri-implant Bone Level, run by University of Santiago de Compostela 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 4 inclusion and 15 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 29 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Maceiras (+0034676780483, luciamaceiraspombo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic marginal periimplant bone level changes (time frame: from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later). 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 NCT04385355, which also lists 7 linked publications.
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 29 Sep 2021.