Bone LossNCT06017115

Evaluation of Using Different Screwed Abutment Height

A study of Bone Loss, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A prospective randomized controlled clinical trial will be conducted. Study groups will be assigned as described above. The patients will be randomly divided into two groups in order to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone Level Tapered implants (BLT® Roxolid®… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bone Loss
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: 1 Jul 2017to 1 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Signed informed consent
Overall, healthy subjects
Females and males of at least eighteen-years
Requiring a minimum of two implants (molar and/or premolar teeth)
Adequate oral hygiene (less than 15% FMPS)
Able to follow instructions and attend a regular compliance
Enough bone to place a standard implant of 4.1 mm diameter.

Who cannot join

Acute local infection
Occlusal overload with parafunctional activity (assessed clinically)
Large occlusal discrepancies
Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year)
Smokers (more than 10 cigarettes/day)
Drug and/or alcoholic dependencies

Show all 9Show fewer

Medical conditions contraindicating implant surgery
History of head and/or neck radiation
Bisphosphonate therapy

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universitat Internacional de Catalunya
Barcelona, 08195

Other trials in Spain

About this study

Official title: Evaluation of Straumann Bone Level Tapered® Implants Using Screwed Abutment Height in Partially Edentulous Patients: a Randomized Controlled Clinical Trial

Read the detailed description

48 patients will be selected with partial edentulism in the maxilla or mandible, requiring two dental implants in the posterior areas (molars and premolars).

Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12) and all the implants will be placed by residents of the International Master in Oral Surgery and Master in Periodontics of the same University.

Study groups

Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)

Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:

Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients)
Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients)

Clinical Parameters and Outcomes

Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed tomography superposed with digital cast models).
Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken on the day of surgery, 4, 6, 12, 24 and 36 months following surgery.
Probing depth, bleeding on probing and keratinized mucosa width will be measured in the follow-up visits in 3 different points in buccal (Mesial, center and distal).
VAS Scale: The visual analog scale or visual analog scale (VAS).

Conditions: Bone Loss
Being tested: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)
Keywords: bone loss, dental implant, bone implant interface, Peri implant Endosseous Healing, Dental implant abutment
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.

Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)Device
Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)

Study groups in NCT06017115
Study group	Role	What they receive
Control group	Active comparator	Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery) Receives: Device: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)
Test group	Experimental	Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT Receives: Device: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)

What is being measured

The primary outcome is the main question the study is designed to answer.

Marginal Bone Loss
Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated.
Measured: After implant loading (baseline)and once every year to 24 months follow-up

Secondary outcomes (3)

Probing Depth
Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
Measured: After implant loading (baseline)and once every year to 36 months follow-up
Bleeding on Probing
Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
Measured: After implant loading (baseline)and once every year to 36 months follow-up
Keratinized Mucosa Width
Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
Measured: After implant loading (baseline)and once every year to 36 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20171 Nov 2024

First posted30 Aug 2023
Study start1 Jul 2017
Primary completion30 Jul 2022
Study completion1 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12)
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06017115
Sponsor's protocol ID: CIR-ECL-2016-03
Status last verified: Jun 2025
First submitted: 29 Jun 2023
Last updated: 26 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The investigators will have all the informed consent forms, the clinical study report, the presurgical plan, the CBCT immediately post-surgery, and the outcome variable tables of each follow-up visit.

Publications

Gargallo-Albiol J, Zilleruelo-Pozo MJ, Treserra-Parra A, Lucas-Taule E, Paternostro-Betancourt D, Hernandez-Alfaro F. Marginal Bone Loss Around Bone-Level Fully Guided Implants With Direct Implant Connection Versus Intermediate Abutment: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Aug;37(8):970-982. doi: 10.1111/clr.70141. Epub 2026 Jun 1.
PubMed 42226307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bone Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Straumann Bone Level Tapered® Implants Using Screwed Abutment Height in Partially Edentulous Patients: a Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT06017115
Acronym / sponsor ID: CIR-ECL-2016-03
Conditions: Bone Loss
Keywords: bone loss, dental implant, bone implant interface, Peri implant Endosseous Healing, Dental implant abutment
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Universitat Internacional de CatalunyaUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 30 Jul 2022 (actual)
Study completion: 1 Nov 2024 (actual)
First posted: 30 Aug 2023 (actual)
Results: Posted 26 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

48 patients will be selected with partial edentulism in the maxilla or mandible, requiring two dental implants in the posterior areas (molars and premolars).

Study groups

Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)

Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:

Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients)
Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients)

Clinical Parameters and Outcomes

Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed tomography superposed with digital cast models).
Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken on the day of surgery, 4, 6, 12, 24 and 36 months following surgery.
Probing depth, bleeding on probing and keratinized mucosa width will be measured in the follow-up visits in 3 different points in buccal (Mesial, center and distal).
VAS Scale: The visual analog scale or visual analog scale (VAS).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12)

Arm	Type	Receives
Control group	Active comparator	Device: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery)
Test group	Experimental	Device: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Signed informed consent
Overall, healthy subjects
Females and males of at least eighteen-years
Requiring a minimum of two implants (molar and/or premolar teeth)
Adequate oral hygiene (less than 15% FMPS)

Key exclusion criteria (9 listed)

Acute local infection
Occlusal overload with parafunctional activity (assessed clinically)
Large occlusal discrepancies
Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year)
Smokers (more than 10 cigarettes/day)

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
Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)	Device	Control group, Test group

Primary outcome

Marginal Bone Loss
Time frame: After implant loading (baseline)and once every year to 24 months follow-up
Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated.

3 secondary outcomes

Probing Depth
Time frame: After implant loading (baseline)and once every year to 36 months follow-up
Bleeding on Probing
Time frame: After implant loading (baseline)and once every year to 36 months follow-up
Keratinized Mucosa Width
Time frame: After implant loading (baseline)and once every year to 36 months follow-up

Results and safety

Results posted to the registry on 26 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	12	12
Test Group	18	18

Primary outcome: Marginal Bone Loss

Time frame: After implant loading (baseline)and once every year to 24 months follow-up. Mean (Standard Deviation). Unit: millimeters

Measure	Control Group n = 12	Test Group n = 18
Total implants at 24 months	1.17 (0.35)	0.83 (0.25)
Mesial implant at 24 months	1.28 (0.47)	0.96 (0.36)
Distal implant at 24 months	1.06 (0.53)	0.71 (0.27)
Total implants at 12 months	1.13 (0.34)	0.80 (0.26)
Mesial implant at 12 months	1.25 (0.46)	0.93 (0.38)
Distal implant at 12 months	0.81 (0.41)	0.67 (0.27)

Population analysed: A total of 30 patients (60 implants), 12 of the control group (24 implants) and 18 of the test group (36 implants) were assessed after 24 months follow-up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Test Group	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42226307Gargallo-Albiol J, Zilleruelo-Pozo MJ, Treserra-Parra A, Lucas-Taule E, Paternostro-Betancourt D, Hernandez-Alfaro F. Marginal Bone Loss Around Bone-Level Fully Guided Implants With Direct Implant Connection Versus Intermediate Abutment: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Aug;37(8):970-982. doi: 10.1111/clr.70141. Epub 2026 Jun 1.
Individual participant dataSharing planned: Yes. The investigators will have all the informed consent forms, the clinical study report, the presurgical plan, the CBCT immediately post-surgery, and the outcome variable tables of each follow-up visit.

Related trials for Bone Loss

RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
Recruiting
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Recruiting
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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.

Jordi Gargallo-Albiol principal investigator

Universitat Internacional de Catalunya

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Bone Loss, run by Universitat Internacional de Catalunya 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 7 inclusion and 9 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 26 Jun 2025. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: After implant loading (baseline)and once every year to 24 months follow-up). 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 NCT06017115, 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 26 Jun 2025.