Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health

Peri-Implantitis Clinical Trial

Official title:

Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166017
• Other study ID #: GeorgeEastmanDH
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: George Eastman Dental Hospital, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cross-sectional study involving the measurement of the width of lingual keratinized tissue (in the implant locations) in fully edentulous patients restored with dental implants. The width of KT will be correlated with the primary outcome, diagnosis of peri-implantitis, defined as Probing depth (PPD)>= 6 mm, inflammation/ bleeding on probing (BOP) and bone loss >= 3 mm from the implant platform.

Description:

The study will be conducted with a cross-sectional design. All clinical parameters (width of buccal and lingual keratinized tissue, probing depth, bleeding on probing, plaque, crestal bone loss, gingival index, suppuration) will be collected in mandibular implants in fully edentulous lower arches. The width of lingual band of keratinized tissue (KT) will be be correlated with diagnosis of peri-implantitis or peri-implant mucositis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Osseointegrated (non-mobile) and loaded dental implant

• Mandibular implants

• Full-arch implant-supported prostheses

• Removable full-arch prostheses

• Fixed full-arch prostheses

Exclusion Criteria:

• Implants loaded less than 12 months before examination

• Mobile (non integrated) implants

• Partially edentulous patients

Related Conditions & MeSH terms

• Gingival Recession
• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis
• Recession, Gingival

Intervention

Other:
• Exposure to minimal amount of lingual keratinized tissue width
measurement of clinical parameters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
George Eastman Dental Hospital, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous)	dichotomous (yes or no) outcome composed by PPD (mm), BoP/SOP (yes or no dichotomous) and bone loss (mm, assessed on radiograph)	Day 1
Secondary	Mucosal recession	Distance (mm) between the prosthetic margin/ locator and the mucosal margin	Day 1
Secondary	Bleeding on probing (BOP)	dichotomous measure of mucosal inflammation detected via periodontal probe	Day 1
Secondary	Probing pocket depth (PPD)	distance between the mucosal margin and the bottom of the sulcus/ pocket (mm)	Day 1
Secondary	Self-assessed Brushing discomfort	Rated by patient on Visual analog score (100 mm) to define the amount of discomfort during brushing, with 0 being the minimum and 100 being maximum discomfort. The patient will be asked to rate their level of discomfort by placing an X over the line. The distance from 0 to the X will be measured and converted into a percentage of the entire length of the line.	Day 1
Secondary	Crestal bone loss (mm)	Measured on radiograph (in mm) between the implant shoulder and the most coronal location of the crestal bone	Day 1
Secondary	Suppuration on probing	measured dichotomously (yes/no) when probing an implant	Day 1
Secondary	Diagnosis of mucositis	dichotomous (yes/no) presence of mucosal peri-implant inflammation in the absence of crestal bone loss	Day 1