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

NCT ID: NCT06006156

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Edentulous Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Treatment assignments will be sealed in opaque envelopes that will be opened during the surgery. The treatment assignment will be disclosed to the surgeon after the elevation of the alveolar mucosal flaps and prior to the preparation of the recipient sites.

Study Groups

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dental implant with a convergent collar

One 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).

Group Type EXPERIMENTAL

Dental implants placement

Intervention Type PROCEDURE

surgery for placement of two one-piece trans gingival implants

dental implant with a divergent collar

One 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).

Group Type ACTIVE_COMPARATOR

Dental implants placement

Intervention Type PROCEDURE

surgery for placement of two one-piece trans gingival implants

Interventions

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Dental implants placement

surgery for placement of two one-piece trans gingival implants

Intervention Type PROCEDURE

Other Intervention Names

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implant supported prosthetic restoration

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Nacional de Trujillo

UNKNOWN

Sponsor Role collaborator

ARDEC Academy

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidad Nacional de Trujillo

Trujillo, La Libertad, Peru

Site Status

Countries

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Peru

References

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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.

Reference Type RESULT
PMID: 30768662 (View on PubMed)

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.

Reference Type RESULT
PMID: 31372602 (View on PubMed)

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.

Reference Type RESULT
PMID: 31044538 (View on PubMed)

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.

Reference Type RESULT
PMID: 12019706 (View on PubMed)

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.

Reference Type RESULT
PMID: 25220835 (View on PubMed)

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.

Reference Type RESULT
PMID: 19221195 (View on PubMed)

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.

Reference Type RESULT
PMID: 21486176 (View on PubMed)

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.

Reference Type RESULT
PMID: 30328206 (View on PubMed)

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.

Reference Type RESULT
PMID: 31711077 (View on PubMed)

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.

Reference Type RESULT
PMID: 31274666 (View on PubMed)

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.

Reference Type RESULT
PMID: 27333011 (View on PubMed)

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.

Reference Type RESULT
PMID: 25692556 (View on PubMed)

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.

Reference Type RESULT
PMID: 30430655 (View on PubMed)

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.

Reference Type RESULT
PMID: 28370406 (View on PubMed)

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.

Reference Type RESULT
PMID: 30246182 (View on PubMed)

Szathvary I, Caneva M, Caneva M, Bressan E, Botticelli D, Meneghello R. A volumetric 3-D digital analysis of dimensional changes to the alveolar process at implants placed immediately into extraction sockets. J Oral Science Rehabilitation. 2015 Sep;1(1):62-9.

Reference Type RESULT

Welander M, Abrahamsson I, Berglundh T. Subcrestal placement of two-part implants. Clin Oral Implants Res. 2009 Mar;20(3):226-31. doi: 10.1111/j.1600-0501.2008.01637.x.

Reference Type RESULT
PMID: 19397633 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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UNT_short implants

Identifier Type: -

Identifier Source: org_study_id

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