Clinical trial NCT04874467: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Peri-implant Mucositis
Compliance, Patient
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Bleeding on probing
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: International University of Catalunya
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Jose Nart, DDS PhD
role: STUDY_CHAIR
References: