Peri-implant Health of Dental Implants in the Posterior Region; an Evaluation After 10 Years

NCT05650099 | Completed

• 1 other identifier: 11103
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

• Background Adaptation of a dental implant and its restoration to the existing anatomy in the region of a missing tooth is presumed to be a reliable procedure. During the follow-up it appears that peri-implant bone level is stable, peri-implant soft tissues are healthy and patients are satisfied with the result. However, the number of 10-years studies on implants in the posterior region of maxilla and mandible is limited and much more studies with longer follow-up periods are needed to confirm the positive outcomes.
• Main research question The primary objective of the study is marginal bone level changes by radiological assessments at 10-years follow-up. Secondary objectives are implant and restoration survival, condition of peri- implant mucosa and patients' satisfaction.
• Design The study design is an observational study of a group of patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region. 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, peri-implant mucosa health 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)

Implants in the posterior region

126 patients with one or two missing tooth/teeth in the posterior region were treated 10 years ago with dental implant treatment and implant-supported restorations

Device: One or two dental implants (Biomet3I dental implant system) were placed 10 years ago

Interventions

One or two dental implants (Biomet3I dental implant system) 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 missing posterior teeth 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)

Implants in the posterior region

Eligibility Criteria

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

Study Population

The study design is an observational study of a group of 126 patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region.

You may qualify if:

• Patients referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with a dental implant and an implant-supported restoration because of having a missing tooth in the posterior region. At the time of treatment:
• The patient was 18 years or older;
• The missing tooth was a premolar or molar in maxilla or mandible;
• Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8.5 mm and at least 4.0 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)

• Telleman G, Raghoebar GM, Vissink A, Meijer HJ. Impact of platform switching on inter-proximal bone levels around short implants in the posterior region; 1-year results from a randomized clinical trial. J Clin Periodontol. 2012 Jul;39(7):688-97. doi: 10.1111/j.1600-051X.2012.01887.x. Epub 2012 Apr 29.

  PMID: 22540412 BACKGROUND

• Telleman G, Meijer HJ, Vissink A, Raghoebar GM. Short implants with a nanometer-sized CaP surface provided with either a platform-switched or platform-matched abutment connection in the posterior region: a randomized clinical trial. Clin Oral Implants Res. 2013 Dec;24(12):1316-24. doi: 10.1111/clr.12000. Epub 2012 Sep 10.

  PMID: 22957911 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

  UMCG Groningen, Netherlands

  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: December 6, 2022
• First Posted: December 14, 2022
• Study Start: October 6, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: March 30, 2025

Record last verified: 2023-10

Locations

NL (1)