Periimplant Bone LossNCT04369170
Changes on the Interproximal Bone Level on Direct Prostheses or With Intermediate Abutments
A study testing prosthesis connected directly to the implants and Intermediate abutment in people with Periimplant Bone Loss and Marginal Periimplant Bone Level, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
Study Title: Changes on the Interproximal marginal bone level after CAD-CAM designed bridges directly placed on bone-level implants, or with intermediate abutments. A Randomized Clinical Trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periimplant Bone Loss, Marginal Periimplant Bone Level, Periimplantitis
- What is being tested?
- prosthesis connected directly to the implants and Intermediate abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2019to 25 Oct 2022
- 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
- Patients with systemic and periodontal health, over 18 years old, with a Plaque Index lower than 25%.
- Patients with an absence of at least two contiguous teeth, with natural proximal teeth, excluding the anterior upper zone, allowing the rehabilitation with bridges with two implants and two to four prostheses units
- Adequate bone quality available that allows the placement of MOZO GRAU® INHEX ST implants with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm.
- At least 2mm of keratinized gingiva.
- Natural antagonic teeth or implants with fixed restorations.
Who cannot join
- • Systemic Factors:
- Long term use of systemic medication that may interfere with bone metabolism or medical conditions that require prolonged use of steroids and / or medication that may interfere with bone metabolism
- History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, renal failure or bonemetabolic disorders such as osteoporosis
- Physical disabilities that may interfere with proper oral hygiene
- Use of any medication or device in research for a period of 30 days prior to the implant surgery in the study
- Alcoholism or drug abuse
Show all 17Show fewer
- Smoker of more than 10 cigarettes per day
- Conditions or circumstances which could prevent compliance with the participation in the study or interfere with the analysis of the results, such as a history of non-compliance or lack of reliability.
- Local Factors:
- History of local radiotherapy
- Bruxism
- Mucosal diseases, such as Oral Lichen Planus
- Not treated periodontitis
- Persistent intraoral infection
- Crestal bone regeneration less than 3 months before the implant placement
- Not healed extraction sockets (less than 6 weeks post-extraction
- Anterior aesthetic sextant of the maxilla
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Santiago de Compostela
Santiago de Compostela, La Coruña, 15782
About this study
Official title: Changes on the Interproximal Marginal Bone Level After CAD-CAM Designed Bridges Directly Placed on Bone-level Implants, or With Intermediate Abutments. A Randomized Clinical Trial
Study Title: Changes on the Interproximal marginal bone level after CAD-CAM designed bridges directly placed on bone-level implants, or with intermediate abutments. A Randomized Clinical Trial.
- Objectives: To evaluate differences on changes on the interproximal marginal bone level 12 months after the connection of CAD/CAM designed prosthesis with an intermediate abutment (3mm long) or directly placed to bonelevel implants. Secondary objectives will be evaluate changes on the soft tissues and implant survival, as well as patients' satisfaction 3, 6 and 12 months after the connection of the definitive prosthesis.
- Design and Outcomes: Randomized double-blinded clinical trial with parallel design to asses the effect of CADCAM designed bridges directly placed
- Interventions and Duration: Patients will be selected according to the inclusion/exclusion criteria among those who attend the Unit of Periodontology of the University of Santiago de Compostela. After clinical and radiological implant planning, implant surgical placement will be scheduled. 2 MOZO GRAU® INHEX ST implants, with 3.75 mm or 4.25 mm of diameter and 8mm, 10mm or 11.5mm length will be placed on each patient, according to the bone availability. After 8 weeks of submerged healing, second stage surgery will be performed and definitive impression will be taken. All groups patients will keep a heeling abutment until the definitive prosthesis is placed, 3 weeks later (test group: direct to implant / control group: abutment 3 mm long). Clinical and radiological assessment after 1, 3, 6 and 12 months will be performed. Each participant will be on study about 15 months since the recruitment visit until the end of the study.
- Sample Size and Population: Based on previous studies, a sample size calculation determined that a group of 32 subjects, considering possible dropouts, will provide 80% power to detect a true radiographic difference of 0.80mm between groups after 12 months of observation since the definitive prosthesis connection. (Blanco et al 2017, Nóvoa et al 2017). A common standard deviation between groups was calculated (SD=0.715268015). A p ≤ 0.05 value will be considered significant (JM. Domenech \& R. Granero 2010). A balanced random permuted block will be applied to prepare the randomization tables, stratifying for smoking habits (yes/no) with a 1:1 ratio between test and control groups.
Read the detailed description
Changes on the interproximal periimplant marginal bone level measured as the distance between the bone crest to the first implant to bone contact, using periapical radiographs, will be evaluated.
Each patient will receive to implants that will be rehabilitated with an implant supported prosthesis, being the test group a prosthesis connected directly to the implants, while the control group will be a prosthesis connected to the implants through intermediate abutments.
- Being tested
- prosthesis connected directly to the implants, Intermediate abutment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthesis connected directly to the implantsDevice
dental prostheses connected directly to the dental implants
Intermediate abutmentDevice
dental prostheses connected with an intermediate abutment to the implant
| Study group | Role | What they receive |
|---|---|---|
| Group A - Control Group | Other | Control group where an intermediate abutment is placed in between the CAD-CAM dental prostheses an the dental implant. Receives: Device: Intermediate abutment |
| Group B - Test Group | Experimental | Test group where the CAD-CAM dental prostheses is connected directly to the dental implant Receives: Device: prosthesis connected directly to the implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Periimplant Marginal Bone Loss
distance in millimetres measured on the periapical radiography between the implant neck and the first bone to implant contact after 12 months of loading
Measured: 12 months after the connection of the definitive prosthesis
Secondary outcomes (6)
Aesthetic parameters according to papilla refill between the prosthetic units
Using the Jemt index 1997 to evaluate the papilla refill between the prosthetic units
Measured: 12 months after the connection of the definitive prosthesis
PROM's - Patient Recorded Outcomes Measurements
Visual Analogue Scale from 1 to 10 where the patient can evaluate the treatment according to aesthetics, chewing capacity, phonetics, confort and general satisfaction with the treatment
Measured: 12 months after the connection of the definitive prosthesis
Adverse events
prostheses fracture, implant fracture, biological complications
Measured: 12 months after the connection of the definitive prosthesis
probing pocket depth
measured with a CP12 calibrated periodontal probe from the gingival margin to the end of the periimplant pocket
Measured: 12 months after the connection of the definitive prosthesis
Bleeding on probing
presence of bleeding after probing pocket depth using the Mombelli index 1987
Measured: 12 months after the connection of the definitive prosthesis
Plaque index
presence of plaque on the implant supported rehabilitation using the Mombelli index 1987
Measured: 12 months after the connection of the definitive prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start25 Apr 2019
- Primary completion25 Oct 2021 (estimated)
- Study completion25 Oct 2022 (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 Periimplant 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
- Parallel blinded clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Mozo Grau S.A.
- Responsible party
- Principal investigator, Juan Blanco Carrión, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369170
- Sponsor's protocol ID
- ECIMG07/17
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 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 24735458Belser UC, Schmid B, Higginbottom F, Buser D. Outcome analysis of implant restorations located in the anterior maxilla: a review of the recent literature. Int J Oral Maxillofac Implants. 2004;19 Suppl:30-42.
PubMed 15635944Blanco 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 29222809Novoa 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 28817138Piao CM, Lee JE, Koak JY, Kim SK, Rhyu IC, Han CH, Herr Y, Heo SJ. Marginal bone loss around three different implant systems: radiographic evaluation after 1 year. J Oral Rehabil. 2009 Oct;36(10):748-54. doi: 10.1111/j.1365-2842.2009.01988.x. Epub 2009 Aug 20.
PubMed 19702681Tomasi C, Tessarolo F, Caola I, Wennstrom J, Nollo G, Berglundh T. Morphogenesis of peri-implant mucosa revisited: an experimental study in humans. Clin Oral Implants Res. 2014 Sep;25(9):997-1003. doi: 10.1111/clr.12223. Epub 2013 Jun 26.
PubMed 23799997Maceiras L, Linares A, Novoa L, Batalla P, Mareque S, Perez J, Blanco J. Marginal changes at bone-level implants supporting dental prostheses with or without intermediate standardised abutments after 36 months: Randomised controlled clinical trial. Clin Oral Implants Res. 2024 Sep;35(9):1072-1080. doi: 10.1111/clr.14297. Epub 2024 May 26.
PubMed 38797975
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
- Changes on the Interproximal Marginal Bone Level After CAD-CAM Designed Bridges Directly Placed on Bone-level Implants, or With Intermediate Abutments. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04369170
- Acronym / sponsor ID
- ECIMG07/17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Mozo Grau S.A.
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 25 Oct 2021 (estimated)
- Study completion
- 25 Oct 2022 (estimated)
- First posted
- 30 Apr 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.
Study Title: Changes on the Interproximal marginal bone level after CAD-CAM designed bridges directly placed on bone-level implants, or with intermediate abutments. A Randomized Clinical Trial.
- Objectives: To evaluate differences on changes on the interproximal marginal bone level 12 months after the connection of CAD/CAM designed prosthesis with an intermediate abutment (3mm long) or directly placed to bonelevel implants. Secondary objectives will be evaluate changes on the soft tissues and implant survival, as well as patients' satisfaction 3, 6 and 12 months after the connection of the definitive prosthesis.
- Design and Outcomes: Randomized double-blinded clinical trial with parallel design to asses the effect of CADCAM designed bridges directly placed
- Interventions and Duration: Patients will be selected according to the inclusion/exclusion criteria among those who attend the Unit of Periodontology of the University of Santiago de Compostela. After clinical and radiological implant planning, implant surgical placement will be scheduled. 2 MOZO GRAU® INHEX ST implants, with 3.75 mm or 4.25 mm of diameter and 8mm, 10mm or 11.5mm length will be placed on each patient, according to the bone availability. After 8 weeks of submerged healing, second stage surgery will be performed and definitive impression will be taken. All groups patients will keep a heeling abutment until the definitive prosthesis is placed, 3 weeks later (test group: direct to implant / control group: abutment 3 mm long). Clinical and radiological assessment after 1, 3, 6 and 12 months will be performed. Each participant will be on study about 15 months since the recruitment visit until the end of the study.
- Sample Size and Population: Based on previous studies, a sample size calculation determined that a group of 32 subjects, considering possible dropouts, will provide 80% power to detect a true radiographic difference of 0.80mm between groups after 12 months of observation since the definitive prosthesis connection. (Blanco et al 2017, Nóvoa et al 2017). A common standard deviation between groups was calculated (SD=0.715268015). A p ≤ 0.05 value will be considered significant (JM. Domenech \& R. Granero 2010). A balanced random permuted block will be applied to prepare the randomization tables, stratifying for smoking habits (yes/no) with a 1:1 ratio between test and control groups.
Detailed description
Changes on the interproximal periimplant marginal bone level measured as the distance between the bone crest to the first implant to bone contact, using periapical radiographs, will be evaluated.
Each patient will receive to implants that will be rehabilitated with an implant supported prosthesis, being the test group a prosthesis connected directly to the implants, while the control group will be a prosthesis connected to the implants through intermediate abutments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A - Control Group | Other | Device: Intermediate abutmentControl group where an intermediate abutment is placed in between the CAD-CAM dental prostheses an the dental implant. |
| Group B - Test Group | Experimental | Device: prosthesis connected directly to the implantsTest group where the CAD-CAM dental prostheses is connected directly to the dental implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with systemic and periodontal health, over 18 years old, with a Plaque Index lower than 25%.
Key exclusion criteria (17 listed)
- • Systemic Factors:
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 |
|---|---|---|
| prosthesis connected directly to the implantsdental prostheses connected directly to the dental implants | Device | Group B - Test Group |
| Intermediate abutmentdental prostheses connected with an intermediate abutment to the implant | Device | Group A - Control Group |
Primary outcome
Radiographic Periimplant Marginal Bone Loss
Time frame: 12 months after the connection of the definitive prosthesis
distance in millimetres measured on the periapical radiography between the implant neck and the first bone to implant contact after 12 months of loading
6 secondary outcomes
Aesthetic parameters according to papilla refill between the prosthetic units
Time frame: 12 months after the connection of the definitive prosthesis
PROM's - Patient Recorded Outcomes Measurements
Time frame: 12 months after the connection of the definitive prosthesis
Adverse events
Time frame: 12 months after the connection of the definitive prosthesis
probing pocket depth
Time frame: 12 months after the connection of the definitive prosthesis
Bleeding on probing
Time frame: 12 months after the connection of the definitive prosthesis
Plaque index
Time frame: 12 months after the connection of the definitive prosthesis
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 15635944Belser UC, Schmid B, Higginbottom F, Buser D. Outcome analysis of implant restorations located in the anterior maxilla: a review of the recent literature. Int J Oral Maxillofac Implants. 2004;19 Suppl:30-42.
- 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 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 19702681Piao CM, Lee JE, Koak JY, Kim SK, Rhyu IC, Han CH, Herr Y, Heo SJ. Marginal bone loss around three different implant systems: radiographic evaluation after 1 year. J Oral Rehabil. 2009 Oct;36(10):748-54. doi: 10.1111/j.1365-2842.2009.01988.x. Epub 2009 Aug 20.
- Background: PubMed 23799997Tomasi C, Tessarolo F, Caola I, Wennstrom J, Nollo G, Berglundh T. Morphogenesis of peri-implant mucosa revisited: an experimental study in humans. Clin Oral Implants Res. 2014 Sep;25(9):997-1003. doi: 10.1111/clr.12223. Epub 2013 Jun 26.
- Derived from this study: PubMed 38797975Maceiras L, Linares A, Novoa L, Batalla P, Mareque S, Perez J, Blanco J. Marginal changes at bone-level implants supporting dental prostheses with or without intermediate standardised abutments after 36 months: Randomised controlled clinical trial. Clin Oral Implants Res. 2024 Sep;35(9):1072-1080. doi: 10.1111/clr.14297. Epub 2024 May 26.
- 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 study testing prosthesis connected directly to the implants and Intermediate abutment in people with Periimplant Bone Loss and Marginal Periimplant 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 5 inclusion and 17 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?
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?
Radiographic Periimplant Marginal Bone Loss (time frame: 12 months after the connection of the definitive prosthesis). 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 NCT04369170, 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.