Clinical and Radiographic Outcomes of Dental Implant Therapy

Peri-Implantitis Clinical Trial

Official title:

Clinical and Radiographic Outcomes of Dental Implant Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825772
• Other study ID #: Jan1
• Status: Completed
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2022
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

900 subjects having received dental implants 9-10 years ago are invited for a clinical and radiographic examination. The individuals were randomly selected from the National Health Insurance data register in Sweden.

The clinical and radiographic examination of the 900 selected subjects will include assessments of implant loss, loss of prosthesis and technical / biological complications.

Biological complications will be assessed from the findings in the clinical and radiographic examinations. Thus, signs of pathology in peri-implant tissues, probing pocket depth (PPD) and bleeding/pus on probing (BoP) will be recorded. Marginal bone loss and other findings in radiographs will also be evaluated.

The prevalence, extent and severity of peri-implantitis will hereby be determined. Patient-centered outcomes will also be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

A questionnaire was distributed to the 4716 identified subjects. 3827 questionnaires (81.15%) were returned and, hence, included in the analysis.

From the sample of 3827 patients who responded to the questionnaire, 3107 (81.19%) gave their consent for access of patient files/records.

Patient files/records of 2780 individuals could be collected from the treating dentists (89.48%). Out of the 2780, 900 individuals were selected by random sampling, stratifying only for the two age groups.

Inclusion Criteria:

• Having received implants within the Swedish insurance system in 2003/2004.

• Being in one of the two age groups in 2003: 65-75 years and 45 - 55 years.

• Having answered the initial questionnaire

• Treating dentist provided patient files/records

Exclusion Criteria:

• Having died during the study period (collection of questionnaire and patient files/records)

Related Conditions & MeSH terms

• Peri-Implantitis

Locations

Country	Name	City	State
Sweden	Department of Periodontology, Institute of Odontology	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Swedish Social Insurance Agency, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Berglundh T, Persson L, Klinge B. A systematic review of the incidence of biological and technical complications in implant dentistry reported in prospective longitudinal studies of at least 5 years. J Clin Periodontol. 2002;29 Suppl 3:197-212; discussion 232-3. Review. — View Citation

Fransson C, Lekholm U, Jemt T, Berglundh T. Prevalence of subjects with progressive bone loss at implants. Clin Oral Implants Res. 2005 Aug;16(4):440-6. — View Citation

Tomasi C, Derks J. Clinical research of peri-implant diseases--quality of reporting, case definitions and methods to study incidence, prevalence and risk factors of peri-implant diseases. J Clin Periodontol. 2012 Feb;39 Suppl 12:207-23. doi: 10.1111/j.1600-051X.2011.01831.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical complications	Technical complications relating to implant components or the prosthetic reconstruction are recorded. Recorded complications are (i) acrylic/porcelain fractures, (ii) screw-loosening and decementation, (iii) abutment screw loosening or fractures and (i) implant fractures.	9-10 years after receiving dental implants
Primary	Peri-implantitis	All subjects were provided with dental implants in 2003/2004. The clinical and radiographic examinations will be carried out in 2013.	9-10 years following implant installation
Secondary	Implant loss		9-10 years after having received dental implants