Long-term Outcomes of Implants in Patients with Periodontitis

NCT06852599 | Completed

• 1 other identifier: S-476/2023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to examine potential influencing factors on the changes in the periodontal parameters probing pocket depth (PPD), bleeding on probing (BOP), and alveolar bone loss (ABL) on implants and control teeth (using a split-mouth design) over five (T-5), 7.5 (T-7), and ten years (T-10) of supportive periodontal care (SPC). For this purpose, 150 patients with periodontitis and implants are re-examined cross-sectionally (T0), and the changes in the main peri-implant and periodontal target parameters are compared retrospectively at the specified observation time points (T-5, T-7, T-10). Potential influencing factors to peri-implant conditions include patient-related factors, therapy-related factors and implant-related factors. In addition, patients will be surveyed using validated questionnaires on oral health-related quality of life (OHIP-G14), and a number of common risk factors for periodontits and peri-implant conditions.

Conditions

Peri-Implant Health; Periodontitis; Peri-implant Mucositis; Peri-implantitis

Outcome Measures

Primary Outcomes (1)

• changes in periodontal pocket depths

  over five, 7.5, and ten years of supportive periodontal care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohort is recruited from patients of the Department of Conservative Dentistry at Heidelberg University Hospital who have undergone systematic periodontal therapy, have a dental implant, and meet the other inclusion criteria.

You may qualify if:

• Patient-related:
• At least one dental implant present
• Age ≥ 18 years at the beginning of the observation period
• Verbal and written consent
• Complete periodontal and dental status at one of the defined observation time points with 6 probing sites per tooth/implant and bleeding on probing (BOP) recorded during the periodontal maintenance phase
• Locally:
• a contralateral control tooth to the implant is present at the first defined observation time point
• BOP recorded on the implant

You may not qualify if:

• No written and verbal consent
• Younger than 18 years

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Heidelberg University

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Periodontitis; Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: September 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

DE (1)