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Edentulous Alveolar RidgeNCT06006156

Dimensional Changes in Single Crowns Supported by Short Transmucosal Implants With Diverging or Converging Neck Profiles in the Esthetic Zone

A study testing Dental implants placement in people with Edentulous Alveolar Ridge, run by ARDEC Academy at 1 site in Peru.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of the present randomized clinical trial is to assess the long-term osseous and peri-implant soft tissue changes as well as the success rate of short implants (6 mm) with a converging collar with micro threads or a diverging polished collar placed in the esthetic zone of the maxilla on partially edentulous… Read more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Edentulous Alveolar Ridge
What is being tested?
Dental implants placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePeru
Study dates
1 Apr 2023to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Presence of at least two edentulous areas in the esthetic region of the maxilla (from right to left from second premolar to premolar, preferably first premolars and incisors)
  • Alveolar bone ≥ 8 mm in height and ≥ 5 mm in thickness assessed on CBCT.
  • Age of ≥ 21 years.
  • Need for an implant-supported prosthetic restoration.
  • Be in good general health with no contraindications to oral surgical procedures.
  • Not be pregnant.
  • Patients who agree to participate in the study and sign the informed consent.

Who cannot join

  • The presence of any uncontrolled systemic disease.
  • History of past or ongoing chemotherapeutic or radiotherapeutic treatments.
  • Heavy smokers (>10 cigarettes per day).
  • Previous bone regeneration procedures in the area of interest

Trial locations and contacts

1 site in 1 country.

Peru1 site
  • Universidad Nacional de Trujillo

    Trujillo, La Libertad, 13001

Other trials in Peru

About this study

Official title: Long-term Dimensional Changes in Single Crowns Supported by Short (6 mm) Transmucosal Implants With Divergent or Convergent Neck Profiles in the Esthetic Zone. A Randomized Randomized Controlled Clinical Trial

The goal of the present randomized clinical trial is to assess the long-term osseous and peri-implant soft tissue changes as well as the success rate of short implants (6 mm) with a converging collar with micro threads or a diverging polished collar placed in the esthetic zone of the maxilla on partially edentulous patients. The main questions it aims to answer are:

  • what are the long-term bone and soft tissue changes around implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla?
  • What is the success rate of implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla? Dental implants with a converging collar with micro threads or a diverging polished collar will be placed in the esthetic zone of the maxilla of the included participants and the measurements regarding the bone and soft tissue level will be compared.
Read the detailed description

The objectives of the present randomized clinical trial are to evaluate the clinical and radiographic changes over time of hard and soft tissues around implants with a convergent or divergent collar. Twenty volunteer participants with two edentulous regions in the maxillary esthetic zone (from the right second premolar to the left second premolar) will be included in the study. Two implants will be randomly installed, one with a convergent collar and one with a divergent collar. After 3 months of healing, individual crowns will be installed. At each visit the following parameters will be evaluated: plaque index, probing depth, bleeding on probing, the recession of the mucosal margin, intraoral radiographs, likewise control CBCT, and impressions will be performed. The visit will take place at 6 and 12 months and then annually for a minimum of 3 years. Changes at the level of the marginal bone will be assessed overtime on the radiographs. Dimensional changes will be clinically evaluated during control evaluations and later through digital impressions.

Being tested
Dental implants placement
Keywords
Maxilla, Partially edentulous, Dental implant, Implant supported prosthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental implants placementProcedure or surgery

    Also called implant supported prosthetic restoration

    surgery for placement of two one-piece trans gingival implants

Study groups in NCT06006156
Study groupRoleWhat they receive
dental implant with a convergent collarExperimentalOne implant with a converging collar with micro threads will be installed in each patient according to the site randomization in the esthetic region of the upper jaw (between the second premolars).
Receives: Procedure: Dental implants placement
dental implant with a divergent collarActive comparatorOne implant with a diverging polished collar will be installed in each patient according to the site randomization in the esthetic region of the upper jaw ( between the second premolars).
Receives: Procedure: Dental implants placement

What is being measured

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

  1. height of the periimplant bone tissues

    The height of the periimplant bone tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints

    Measured: baseline

  2. height of the periimplant bone tissues

    The height of the periimplant bone tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints

    Measured: 3 years follow up

  3. height of the periimplant soft tissues

    The height of the periimplant soft tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints

    Measured: Baseline

  4. height of the periimplant soft tissues

    The height of the periimplant soft tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints

    Measured: 3 years follow up

Secondary outcomes (8)
  1. Plaque index

    to score the plaque accumulation of plaque around implants will be used the Mombelli et al index

    Measured: 1 year

  2. Plaque index

    to score the plaque accumulation of plaque around implants will be used the Mombelli et al index

    Measured: 3 year

  3. Bleeding on probing

    During the probing, the bleeding on probing will be registered in the periodontal record.

    Measured: 1 year

  4. Bleeding on probing

    During the probing, the bleeding on probing will be registered in the periodontal record.

    Measured: 3 year

  5. Probing depth

    A calibrated probe will be used to measure the probing depth in all teeth annually.

    Measured: 1 year

  6. Probing depth

    A calibrated probe will be used to measure the probing depth in all teeth annually.

    Measured: 3 year

  7. Implant success rate

    The criteria to evaluate the success rate will be if there was no persistent and/or irreversible signs or symptoms such as pain, infection, neuropathies, or paresthesia, no peri-implant infection with suppuration, no mobility, and no continuous radiolucency around the implant.

    Measured: 1 year

  8. Implant success rate

    The criteria to evaluate the success rate will be if there was no persistent and/or irreversible signs or symptoms such as pain, infection, neuropathies, or paresthesia, no peri-implant infection with suppuration, no mobility, and no continuous radiolucency around the implant.

    Measured: 3 years

Timeline

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

  1. First posted23 Aug 2023
  2. Study start1 Apr 2023
  3. Primary completion30 Sep 2025
  4. Study completion30 Dec 2026 (estimated)

Resources

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
The study is a split-mouth randomized controlled trial. One implant with a converging collar with micro threads or a diverging polished collar will be installed in each patient according to randomization in the esthetic region of the upper jaw ( between the second premolars ). It will be restored with individual crowns after three months of healing. Both implants will be placed with the rough margin of \~1 mm subcrestally.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06006156
Sponsor's protocol ID
UNT_short implants
Status last verified
Nov 2025
First submitted
5 Apr 2023
Last updated
17 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agustin-Panadero R, Martinez-Martinez N, Fernandez-Estevan L, Faus-Lopez J, Sola-Ruiz MF. Influence of Transmucosal Area Morphology on Peri-Implant Bone Loss in Tissue-Level Implants. Int J Oral Maxillofac Implants. 2019 July/August;(34):947-952. doi: 10.11607/jomi.7329. Epub 2019 Feb 15.

    PubMed 30768662
  • Altaib FH, Alqutaibi AY, Al-Fahd A, Eid S. Short dental implant as alternative to long implant with bone augmentation of the atrophic posterior ridge: a systematic review and meta-analysis of RCTs. Quintessence Int. 2019;50(8):636-650. doi: 10.3290/j.qi.a42948.

    PubMed 31372602
  • Bitaraf T, Keshtkar A, Rokn AR, Monzavi A, Geramy A, Hashemi K. Comparing short dental implant and standard dental implant in terms of marginal bone level changes: A systematic review and meta-analysis of randomized controlled trials. Clin Implant Dent Relat Res. 2019 Aug;21(4):796-812. doi: 10.1111/cid.12774. Epub 2019 May 1.

    PubMed 31044538
  • Buser D, Ingimarsson S, Dula K, Lussi A, Hirt HP, Belser UC. Long-term stability of osseointegrated implants in augmented bone: a 5-year prospective study in partially edentulous patients. Int J Periodontics Restorative Dent. 2002 Apr;22(2):109-17.

    PubMed 12019706
  • Caneva M, Lang NP, Calvo Guirado JL, Spriano S, Iezzi G, Botticelli D. Bone healing at bicortically installed implants with different surface configurations. An experimental study in rabbits. Clin Oral Implants Res. 2015 Mar;26(3):293-9. doi: 10.1111/clr.12475. Epub 2014 Sep 15.

    PubMed 25220835
  • Doyle AD, Wang FW, Matsumoto K, Yamada KM. One-dimensional topography underlies three-dimensional fibrillar cell migration. J Cell Biol. 2009 Feb 23;184(4):481-90. doi: 10.1083/jcb.200810041. Epub 2009 Feb 16.

    PubMed 19221195
  • Hermann JS, Jones AA, Bakaeen LG, Buser D, Schoolfield JD, Cochran DL. Influence of a machined collar on crestal bone changes around titanium implants: a histometric study in the canine mandible. J Periodontol. 2011 Sep;82(9):1329-38. doi: 10.1902/jop.2011.090728. Epub 2011 Apr 12.

    PubMed 21486176
  • Papaspyridakos P, De Souza A, Vazouras K, Gholami H, Pagni S, Weber HP. Survival rates of short dental implants (</=6 mm) compared with implants longer than 6 mm in posterior jaw areas: A meta-analysis. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:8-20. doi: 10.1111/clr.13289.

    PubMed 30328206
  • Ravida A, Majzoub J, Alassadi M, Saleh MH, Askar H, Wang HL. Impact of Implant Length on Survival of Rough-Surface Implants in Nonaugmented Posterior Areas: A Systematic Review and Meta-Regression Analysis. Int J Oral Maxillofac Implants. 2019 Nov/Dec;34(6):1359-1369. doi: 10.11607/jomi.7509.

    PubMed 31711077
  • Ravida A, Wang IC, Sammartino G, Barootchi S, Tattan M, Troiano G, Laino L, Marenzi G, Covani U, Wang HL. Prosthetic Rehabilitation of the Posterior Atrophic Maxilla, Short (</=6 mm) or Long (>/=10 mm) Dental Implants? A Systematic Review, Meta-analysis, and Trial Sequential Analysis: Naples Consensus Report Working Group A. Implant Dent. 2019 Dec;28(6):590-602. doi: 10.1097/ID.0000000000000919.

    PubMed 31274666
  • Rodriguez X, Navajas A, Vela X, Fortuno A, Jimenez J, Nevins M. Arrangement of Peri-implant Connective Tissue Fibers Around Platform-Switching Implants with Conical Abutments and Its Relationship to the Underlying Bone: A Human Histologic Study. Int J Periodontics Restorative Dent. 2016 Jul-Aug;36(4):533-40. doi: 10.11607/prd.2580.

    PubMed 27333011
  • Rossi F, Botticelli D, Cesaretti G, De Santis E, Storelli S, Lang NP. Use of short implants (6 mm) in a single-tooth replacement: a 5-year follow-up prospective randomized controlled multicenter clinical study. Clin Oral Implants Res. 2016 Apr;27(4):458-64. doi: 10.1111/clr.12564. Epub 2015 Feb 18.

    PubMed 25692556
  • Rossi F, Lang NP, Ricci E, Ferraioli L, Baldi N, Botticelli D. Long-term follow-up of single crowns supported by short, moderately rough implants-A prospective 10-year cohort study. Clin Oral Implants Res. 2018 Dec;29(12):1212-1219. doi: 10.1111/clr.13386. Epub 2018 Dec 6.

    PubMed 30430655
  • Rossi F, Lang NP, Ricci E, Ferraioli L, Marchetti C, Botticelli D. 6-mm-long implants loaded with fiber-reinforced composite resin-bonded fixed prostheses (FRCRBFDPs). A 5-year prospective study. Clin Oral Implants Res. 2017 Dec;28(12):1478-1483. doi: 10.1111/clr.13015. Epub 2017 Mar 28.

    PubMed 28370406
  • Storelli S, Abba A, Scanferla M, Botticelli D, Romeo E. 6 mm vs 10 mm-long implants in the rehabilitation of posterior jaws: A 10-year follow-up of a randomised controlled trial. Eur J Oral Implantol. 2018;11(3):283-292.

    PubMed 30246182

Questions about this trial

What is this clinical trial studying?

A study testing Dental implants placement in people with Edentulous Alveolar Ridge, run by ARDEC Academy at 1 site in Peru.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 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 Peru. 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?

This study is still under way. Results are not available in the source record yet.

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?

height of the periimplant bone tissues (time frame: baseline). The study lists 4 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 NCT06006156, which also lists 17 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 17 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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