Predictive Value of Reduced Keratinized Mucosa on the Secondary Prevention of Peri-implant Mucositis and Periimplantitis in Patients Attending Regular Supportive Peri-implant Care. A Longitudinal Analysis

NCT05804760 | Completed DMC

• 1 other identifier: 9228_BO_S_2020
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

• Capture of the potential risk factor "lack of band of keratinised mucosa" over a period of up to 5 years.
• Recording of peri-implant inflammatory processes in study participants that are not recorded during normal tooth cleaning
• Registration of the extent of radiographic bone loss. Bone resorption through analysis of existing X-ray images
• Individual therapy recommendation/individual supportive peri-implant care in case of peri-implant inflammation
• The present study was specifically designed to investigate the effect of reduced width of keratinized mucosa (KM) on the secondary prevention of peri-implant mucositis and peri-implantitis in patients attending a supportive peri-implant care program (SPIC) over an observation period of up to five years.

Conditions

Peri-Implantitis; Peri-implant Mucositis; Lack of Keratinized Gingiva

Outcome Measures

Primary Outcomes (1)

• Protective value of keratinized mucosa around dental implants in periodontal healthy patients

  Keratinized mucosa is a significant protective factor for the progression of peri-implant mucositis to severe peri-implant mucositis and to peri-implantitis in patients without history of periodontitis attending regular SPIC over a period of up to five years.

  Up to five years

Secondary Outcomes (1)

• Mucositis severity score (MSS) related to the supported peri implant care (SPIC)

  Up to five years

Study Arms (3)

General population (i)

All participants of the study, including any periodontal condition.

Diagnostic Test: Measurement of implant parameters

Periodontally healthy patients with history of periodontitis (ii)

Patients whose current periodontal condition is healthy but who have developed periodontitis in the past.

Diagnostic Test: Measurement of implant parameters

Periodontally healthy patients without history of periodontitis (iii)

Patients whose current periodontal condition is healthy, who have also not had periodontitis in the past.

Diagnostic Test: Measurement of implant parameters

Interventions

Measurement of implant parameters DIAGNOSTIC_TEST

1. Examination of the inclusion criteria 2. Medical history/patient-specific data (smoking, tumour diseases, radiation, gender, number of implants, history of periodontitis). 3. Recording of implant-specific parameters (measurement depth at six sites per implant(probing depth/PD), bleeding and or pus on probing (BOP) at six measurement sites per implant, condition of the peri-implant mucosa using the modified plaque index(mPI) and the modified ginigiva index (mGI), measurement of the width of the keratinised mucosa(KM), type of denture, approximal plaque index (API), radiographically detectable bone resorption.

General population (i); Periodontally healthy patients with history of periodontitis (ii); Periodontally healthy patients without history of periodontitis (iii)

Eligibility Criteria

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

Study Population

104 patients with at least one root-shaped dental implant who took part in one of the previous studies and who were attending supportive peri-implant care (SPIC) at the Department of Prosthetic Dentistry and Biomedical Materials Science of Hannover Medical School were asked to participate in the study.

You may qualify if:

• \- Patients aged at least 18 years who have at least one root-form dental implant in situ and were part of the first (DOI10.1111/clr.13432) and/or the second (DOI 10.1007/s00784-020-03422-1) observational study

You may not qualify if:

• Systemic antibiotic use up to 3 months before the examination
• pregnancy
• lactating mothers

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: February 12, 2020
• Primary Completion: October 23, 2020
• Study Completion: December 17, 2020
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

DE (1)