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Influence of Keratinized Mucosa on Dental Implants With Mucositis

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supportive periodontal therapy
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peri-Implantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients> 18 years;
  • smokers <10 cigarettes / day;
  • partially edentulous patients. The spaces must be associated with at least one adjacent mesial and one distal tooth;
  • presence of bleeding and / or suppuration on probing, erythema and inflammation;
  • absence of radiographic bone loss around implant distance (<2mm from expected radiographic marginal bone level);
  • individual dental implants rehabilitated for more than a year;
  • screw-retained restorations on implants;
  • absence of active periodontal disease;
  • who have not taken systemic antibiotics in the last 3 months;
  • adequate oral hygiene motivation and collaboration defined as plaque index <25%

Exclusion Criteria:

  • totally edentulous patients;
  • uncontrolled systemic diseases;
  • diseases of the mucosa (erosive lichen planus, etc.);
  • taking medications that may interfere with periodontal health or healing; (corticosteroids, calcium channel antagonists, antiepileptic drugs, immunosuppressants, etc.)
  • pregnant or lactating patients;
  • cemented implant restorations;
  • restorations on implants over contoured that cannot be corrected.

Sites / Locations

  • International University of Catalunya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Keratinized Mucosa ≥ 2 mm

Keratinized Mucosa < 2 mm

Arm Description

Supportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions

Supportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions

Outcomes

Primary Outcome Measures

Bleeding on probing
The main objective of the study is to evaluate the association between MQ and recurrence of mucositis, comparing the bleeding index on probing (BoP) in implants that have mucositis, in a control group characterized by 2 mm or more of MQ and a test group characterized by less than 2 mm of MQ over a 24-week period after peri-implant maintenance therapy.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2021
Last Updated
August 6, 2022
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04874467
Brief Title
Influence of Keratinized Mucosa on Dental Implants With Mucositis
Official Title
Influence of Keratinized Mucosa on Dental Implants With Mucositis in Patients Undergoing Supportive Periodontal Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
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. Methods: 38 patients presenting one single implant each with a 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Peri-implant Mucositis, Compliance, Patient

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keratinized Mucosa ≥ 2 mm
Arm Type
Experimental
Arm Description
Supportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions
Arm Title
Keratinized Mucosa < 2 mm
Arm Type
Experimental
Arm Description
Supportive periodontal therapy, in teeth by means of ultrasonic devices and manual curettes. In implants using the same devices but made of titanium. Oral hygiene instructions
Intervention Type
Procedure
Intervention Name(s)
Supportive periodontal therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bleeding on probing
Description
The main objective of the study is to evaluate the association between MQ and recurrence of mucositis, comparing the bleeding index on probing (BoP) in implants that have mucositis, in a control group characterized by 2 mm or more of MQ and a test group characterized by less than 2 mm of MQ over a 24-week period after peri-implant maintenance therapy.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients> 18 years; smokers <10 cigarettes / day; partially edentulous patients. The spaces must be associated with at least one adjacent mesial and one distal tooth; presence of bleeding and / or suppuration on probing, erythema and inflammation; absence of radiographic bone loss around implant distance (<2mm from expected radiographic marginal bone level); individual dental implants rehabilitated for more than a year; screw-retained restorations on implants; absence of active periodontal disease; who have not taken systemic antibiotics in the last 3 months; adequate oral hygiene motivation and collaboration defined as plaque index <25% Exclusion Criteria: totally edentulous patients; uncontrolled systemic diseases; diseases of the mucosa (erosive lichen planus, etc.); taking medications that may interfere with periodontal health or healing; (corticosteroids, calcium channel antagonists, antiepileptic drugs, immunosuppressants, etc.) pregnant or lactating patients; cemented implant restorations; restorations on implants over contoured that cannot be corrected.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Nart, DDS PhD
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Study Chair
Facility Information:
Facility Name
International University of Catalunya
City
Barcelona
ZIP/Postal Code
08172
Country
Spain

12. IPD Sharing Statement

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Influence of Keratinized Mucosa on Dental Implants With Mucositis

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