Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation After 10 Years

NCT05359549 | Completed

• 1 other identifier: 202200150
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

• Background Replacement of two missing adjacent teeth is considered a difficult treatment in implant dentistry and even more challenging if located in the anterior region due to aesthetic demands. As well peri-implant bone contour as soft tissue volume is compromised at start of the treatment and difficult to restore. The question is if this reconstruction will be stable in the longterm. Full-scale evaluation of adjacent implant placement with crown rehabilitation in the aesthetic region with a follow-up of at least 10 years is underreported in this field of implant dentistry.
• Main research question The aim of this observational study was to analyze peri-implant bone changes, mucosa levels, aesthetic ratings and patient-reported satisfaction with the maxillary aesthetic region following implant placement with crown restoration after a 10-years follow-up period.
• Design (including population, confounders/outcomes) The study design is an observational study of a group of patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations. Outcomes: primary outcome is the change in marginal peri-implant bone level 10 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival and changes in interproximal peri-implant mucosa, midfacial peri-implant mucosal level , aesthetic outcome assessed by means of an objective index and patients' satisfaction using a questionnaire.
• Expected results Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.

Conditions

Missing Teeth

Keywords

dental implants

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant marginal bone level

  Change in peri-implant marginal bone level along the implant side measured on radiographs in millimetres

  Comparison initial radiograph with radiograph after 10 years

Secondary Outcomes (4)

• Implant survival

  10 years

• Restoration survival

  10 years

• Peri-implant soft tissue health

  Status at 10 years

• Patient satisfaction

  Satisfaction at 10 years

Study Arms (1)

Two adjacent dental implants

25 patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.

Device: Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago

Interventions

Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago DEVICE

All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients)

Two adjacent dental implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations.

You may qualify if:

• Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
• The patient was 18 years or older;
• The failing teeth were an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
• Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability \> 45 Ncm
• The implant site was free from infection;
• Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
• Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
• The patient was capable of understanding and giving informed consent.

You may not qualify if:

• Medical and general contraindications for the surgical procedures;
• Presence of an active and uncontrolled periodontal disease;
• Bruxism;
• Smoking
• A history of local radiotherapy to the head and neck region.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Dept Oral and Maxillofacial Surgery UMCG

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (2)

• Tymstra N, Raghoebar GM, Vissink A, Den Hartog L, Stellingsma K, Meijer HJ. Treatment outcome of two adjacent implant crowns with different implant platform designs in the aesthetic zone: a 1-year randomized clinical trial. J Clin Periodontol. 2011 Jan;38(1):74-85. doi: 10.1111/j.1600-051X.2010.01638.x. Epub 2010 Nov 10.

  PMID: 21062337 BACKGROUND

• Van Nimwegen WG, Raghoebar GM, Stellingsma K, Tymstra N, Vissink A, Meijer HJ. Treatment Outcome of Two Adjacent Implant-Supported Restorations with Different Implant Platform Designs in the Esthetic Region: A Five-Year Randomized Clinical Trial. Int J Prosthodont. 2015 Sep-Oct;28(5):490-8. doi: 10.11607/ijp.4199.

  PMID: 26340009 BACKGROUND

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Henny JA Meijer, Prof

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: May 4, 2022
• Study Start: October 6, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 30, 2025

Record last verified: 2023-10

Locations

NL (1)