Narrow ImplantNCT06168500
Narrow Implants Vs Standard Implants With Simultaneous GBR
A study testing Test group in people with Narrow Implant and Dental Implant, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Narrow Implant, Dental Implant, Bone Regeneration
- What is being tested?
- Test group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2021to 28 Dec 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- 18 years old
- Healthy periodontal status (absence of generalized probing pocket depth (PPD) <4mm)
- Oral hygiene levels (FMPS <20 and FMBS <20)
- Site:
- Ridge width of >5mm and <6.5mm and minimum bone height of 10mm prior evaluation on a CBCT scan
Show all 14Show fewer
- Presence of antagonistic natural tooth or fixed prosthetic restoration
- Presence of adjacent teeth
- One maxillary or mandibular premolars
- Minimum of 3mm of keratinized tissue over the bone crest (20)
- Bone regeneration within the limits of the prosthetic restoration.
- Implants:
- Unitary prosthesis
- Screwed retained restorations
Who cannot join
- Patients
- Presence of active chronic or aggressive periodontal disease
- Presence of systemic disease which contraindicate surgery (patients with an ASA ≥ 3)
- Drugs or medications which may alter the results (chronic intake of analgesic medication)
- Smokers (>10cig/day)
- Pregnant women
Show all 16Show fewer
- History of head and neck radiotherapy.
- Site
- Anterior area (from 1.3 to 2.3 and from 3.3 to 4.3) and molar area
- Previous guided bone regeneration
- Location where there is not sufficient restorative space (mesio-distally <8mm for every restoration unit and <5mm from the bone crest to the antagonist)
- Implant dehiscence of more than 2/3 of the implant.
- Implant
- Implants which cannot be restored with a screwed restoration
- Implants which doesn't reach a manual implant stability
- implants which after placement doesn't reach a favourable position according to the restoration.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Narrow Diameter Implants Versus Standard Diameter Implants With Simultaneous Bone Regeneration For The Treatment Of Atrophic Posterior Area
NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by NDI in the posterior area. They observe a survival rate of 97% and absence of prosthetic complications after the study period time. More recently, Souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of NDI and SDI placed in the posterior area of the mandible to support single prosthesis. They observed an implant survival rate of 100% for both groups at 1 and 3 years. The prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively.
NDI present a high survival rate on the evaluated studies. Therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium NDI versus SDI with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.
- Conditions
- Narrow Implant, Dental Implant, Bone Regeneration
- Being tested
- Test group, Control group
- Keywords
- Narrow Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test groupProcedure or surgery
3.0mm diameter implant
Control groupProcedure or surgery
4.0 diameter implant + guided bone regeneration
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Procedure: Test group; Procedure: Control group |
| Control group | Experimental | Not described Receives: Procedure: Test group; Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level difference
To assess the MBL, each radiograph must register the most coronal aspect of the bone crest (BC) at mesial and distal to the implant, the position of the implant shoulder (IS) and the first bone to implant contact (FBiC). The marginal bone crest level (MBL) will be measured by calculating the distance between BC and IS. MBL will be considered negative when position of BC is coronal to IS, positive when position BC is apical to IS.
Measured: The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years.
Secondary outcomes (13)
Patient related outcomes
- Level of discomfort - at 1-, 2- and 12-weeks post-surgery (VAS scale): 0 - 4 (being 0 no discomfort and 4 very severe discomfort)
Measured: At 1, 2 and 12 weeks
Patient Related Outcomes
Willingness of undergoing same surgical procedure - at 1-, 2- and 12-weeks post-surgery (VAS scale): 0 - 4 (being 0 will never undergo this surgery again and 4 no problem to repeat this surgery)
Measured: At 1, 2 and 12 weeks
Patient Related Outcomes
- Level of pain perceived - during first 7 days after surgery (VAS scale): 0-100 (being 0 no pain and 100 intolerable pain)
Measured: At 7 days
Patient Related Outcomes
Medication required: Number of ibuprofen tablets taken between the 2nd and the 7th day.
Measured: At 7 days
Implant survival criteria:
Defined as the implant being still in function
Measured: 12 months
Implant success criteria:
Defined as absence of:
- Persistent pain, foreign body sensation, and/or dysesthesia
- Recurrent peri-implant infection with suppuration
- Implant mobility
- Continuous radiolucency around the implant
- Clinical probing depth (CPD) ≥5 mm associated with bleeding/suppuration on probing (BoP/SoP).
Measured: 12 months
Prosthesis success criteria
- Absence of prosthesis (crown or abutment) mobility
- Number of maintenance visits
- Crown screw loosening
- Abutment screw loosening
- Implant fracture
- Crown screw fracture
- Abutment screw fracture
- Crown chipping.
Measured: 12 months
Resonance frequency analysis
Resonance frequency analysis using Penguin ® will be measured immediately after implant placement, when taking implant impressions
Measured: Implant surgery and after 12 months
Level of keratinized tissue surrounding the implants
Level of keratinized tissue will be measured from the gingival margin of the restored implant to the mucogingival line using a periodontal millimetre probe.
Measured: 12 months
Peri-implant mucosal thickness using a millimetre probe
Measured: 12 months
Presence of post-surgical complications
Defined as absence of:
- Infection/suppuration
- Wound dehiscence
- Implant failure
- Post-op oedema
Measured: At 1, 2 and 12 weeks
Presence of peri-implant health
Defined as:
- Peri-implant probing depth (6 points).
- Bleeding on probing (presence or absence).
- Suppuration on probing (presence or absence).
- Plaque index (presence or absence).
Measured: At 12 weeks, 6 and 12 months
Presence of prosthetic complications
Defined as:
- Number of maintenance visits
- Crown screw loosening ("Yes" or "No")
- Abutment screw loosening ("Yes" or "No")
- Implant fracture ("Yes" or "No")
- Crown screw fracture ("Yes" or "No")
- Abutment screw fracture ("Yes" or "No")
- Framework fracture ("Yes" or "No")
- Crown ceramic chipping ("Yes" or "No")
Measured: At 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start12 Jul 2021
- Primary completion28 Dec 2024
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrow 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Klockner Implant System S.A.
- Responsible party
- Principal investigator, Rodrigo González Terrats, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168500
- Sponsor's protocol ID
- PER-ECL-2018-06
- Status last verified
- May 2024
- First submitted
- 15 Nov 2023
- Last updated
- 11 Mar 2026
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Diameter Implants Versus Standard Diameter Implants With Simultaneous Bone Regeneration For The Treatment Of Atrophic Posterior Area
- ClinicalTrials.gov ID
- NCT06168500
- Acronym / sponsor ID
- PER-ECL-2018-06
- Conditions
- Narrow Implant, Dental Implant, Bone Regeneration
- Keywords
- Narrow Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Klockner Implant System S.A.
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 13 Dec 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.
NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by NDI in the posterior area. They observe a survival rate of 97% and absence of prosthetic complications after the study period time. More recently, Souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of NDI and SDI placed in the posterior area of the mandible to support single prosthesis. They observed an implant survival rate of 100% for both groups at 1 and 3 years. The prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively.
NDI present a high survival rate on the evaluated studies. Therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium NDI versus SDI with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: Test group, Procedure: Control group |
| Control group | Experimental | Procedure: Test group, Procedure: Control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years old
- Healthy periodontal status (absence of generalized probing pocket depth (PPD) <4mm)
- Oral hygiene levels (FMPS <20 and FMBS <20)
- Ridge width of >5mm and <6.5mm and minimum bone height of 10mm prior evaluation on a CBCT scan
- Presence of antagonistic natural tooth or fixed prosthetic restoration
Key exclusion criteria (16 listed)
- Patients
- Presence of active chronic or aggressive periodontal disease
- Presence of systemic disease which contraindicate surgery (patients with an ASA ≥ 3)
- Drugs or medications which may alter the results (chronic intake of analgesic medication)
- Smokers (>10cig/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 |
|---|---|---|
| Test group3.0mm diameter implant | Procedure or surgery | Control group, Test Group |
| Control group4.0 diameter implant + guided bone regeneration | Procedure or surgery | Control group, Test Group |
Primary outcome
Marginal bone level difference
Time frame: The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years.
To assess the MBL, each radiograph must register the most coronal aspect of the bone crest (BC) at mesial and distal to the implant, the position of the implant shoulder (IS) and the first bone to implant contact (FBiC). The marginal bone crest level (MBL) will be measured by calculating the distance between BC and IS. MBL will be considered negative when position of BC is coronal to IS, positive when position BC is apical to IS.
13 secondary outcomes
Patient related outcomes
Time frame: At 1, 2 and 12 weeks
Patient Related Outcomes
Time frame: At 1, 2 and 12 weeks
Patient Related Outcomes
Time frame: At 7 days
Patient Related Outcomes
Time frame: At 7 days
Implant survival criteria:
Time frame: 12 months
Implant success criteria:
Time frame: 12 months
Prosthesis success criteria
Time frame: 12 months
Resonance frequency analysis
Time frame: Implant surgery and after 12 months
Level of keratinized tissue surrounding the implants
Time frame: 12 months
Peri-implant mucosal thickness using a millimetre probe
Time frame: 12 months
Presence of post-surgical complications
Time frame: At 1, 2 and 12 weeks
Presence of peri-implant health
Time frame: At 12 weeks, 6 and 12 months
Presence of prosthetic complications
Time frame: At 6 and 12 months
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 11 Mar 2026.
Related trials for Narrow Implant
RecruitingObservational study
CCM OPEN HF Registry
Heart Failure
RecruitingPhase 2
Clinical and Radiographic Evaluation of Using Regular Versus Narrow Diameter Dental Implantto Support Mandibular Complete Over Denture
DENT IMPLANTS
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
Not yet recruiting
Optimization of Coronary Sinus Lead Placement for CRT Delivery in Non-LBBB or Narrow LBBB Patterns Using Multiparametric 82Rubidium PET-CT Scan Analysis and Cardiac CT Venography
Heart Failure
Not yet recruiting
Clinical and Radiographic Evaluation of Ridge Splitting With Simultaneous Implant Placement Covered With Concentrated Growth Factor Membranes in Narrow Alveolar Ridge
Narrow Alveolar Ridge, CGF Concentrated Growth Factor
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 Test group in people with Narrow Implant and Dental Implant, 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 14 inclusion and 16 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 11 Mar 2026. 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?
Marginal bone level difference (time frame: The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years.). 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 11 Mar 2026.