MedTrace Logo

Influence of Keratinized Mucosa on Dental Implants With Mucositis

NCT04874467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-08-09

No results posted yet for this study

Summary

Introduction:

It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.

There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.

Objectives:

Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM \< 2 mm.

Material and methods:

38 patients presenting one single implant each with a single screw retained crown loaded for at least 1 year. Periodontal maintenance therapy will be performed and oral hygiene instruction will be delivered. Follow up visits will be after 8, 12 and 24 weeks in which the following parameters will be registered: Keratinized Mucosa width, Attached mucosa, Gingival Index, Vestibule Depth, Mucosa Thickness. Probing Pocket Depth, Recession, modified Plaque Index, Bleeding on Probing, modified Bleeding Index. Also a microbiologic test will be taken in the implant sulcus before the periodontal maintenance therapy and at 24 weeks.

A multilevel statistical analysis will be conducted comparing the control and the test group, adjusting for the correlation among multiple observations.

Conditions

  • Peri-Implantitis
  • Peri-implant Mucositis
  • Compliance, Patient

Interventions

PROCEDURE

Supportive periodontal therapy

A complete professional prophylaxis session will be performed, which includes ultrasound debridement, scaling with curettes and dental polishing with a rubber cup. On the other hand, in implants affected by mucositis, supra and sub-gingival debridement will be performed using a combination of ultrasound with a titanium tip and titanium curettes. All patients will receive personalized hygiene instructions. Patients will be instructed to brush their implants twice daily using the modified Bass technique with a medium-hard manual toothbrush and low-abrasive toothpaste. In addition, they will be taught to use specific interproximal brushes. If access with an interdental brush is not possible, flossing will be indicated. Oral hygiene instructions will be reviewed at each visit.

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • Jose Nart, DDS PhD · Universitat Internacional de Catalunya

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04874467 on ClinicalTrials.gov