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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06166017
Enrollment
90
Registered
2023-12-12
Start date
2024-04-30
Completion date
2025-01-31
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed 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.

Interventions

OTHERExposure to minimal amount of lingual keratinized tissue width

measurement of clinical parameters

Sponsors

George Eastman Dental Hospital, Italy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous)Day 1dichotomous (yes or no) outcome composed by PPD (mm), BoP/SOP (yes or no dichotomous) and bone loss (mm, assessed on radiograph)

Secondary

MeasureTime frameDescription
Bleeding on probing (BOP)Day 1dichotomous measure of mucosal inflammation detected via periodontal probe
Probing pocket depth (PPD)Day 1distance between the mucosal margin and the bottom of the sulcus/ pocket (mm)
Self-assessed Brushing discomfortDay 1Rated 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.
Mucosal recessionDay 1Distance (mm) between the prosthetic margin/ locator and the mucosal margin
Suppuration on probingDay 1measured dichotomously (yes/no) when probing an implant
Diagnosis of mucositisDay 1dichotomous (yes/no) presence of mucosal peri-implant inflammation in the absence of crestal bone loss
Crestal bone loss (mm)Day 1Measured on radiograph (in mm) between the implant shoulder and the most coronal location of the crestal bone

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026