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The Impact of Peri-implant Soft Tissue Properties on Patient-reported and Clinically Assessed Outcomes

NCT03396536 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2019-03-12

No results posted yet for this study

Summary

The objective of this study is to evaluate patient discomfort while performing oral hygiene (OH) around implants with and without keratinized mucosa (KM) and assess peri-implant soft tissue esthetic satisfaction and other clinical parameters at the 3- and 6-month follow-up visits. Group 1 will be implants with KM and Group 2 implants without KM. The hypotheses underlying this proposal are (1) that dental implants surrounded by KM will have better patient-reported outcomes regarding discomfort during brushing compared with those that lack KM; (2) that dental implants with KM will show more favorable clinical outcomes (plaque index, bleeding on probing, pocket depth and peri-implant recession) compared with those without KM and (3) that dental implants with KM will have higher patient peri-implant tissue esthetic satisfaction compared with those without KM.

Conditions

  • Keratinized Mucosa

Interventions

OTHER

Evaluation of KM

KM will be evaluated. The alveolar mucosa will be stained with Lugol's solution, by means of a cotton swab. A cotton roll will be soaked in the solution and gently applied on the mucosa around the implant. Since Lugol's solution is selective to the glycogen present in AM, the muco-gingival junction as the borderline between the blue-stained alveolar mucosa and KM can be easily identified. A manual periodontal probe with 1 mm markings will measure the distance from the peri-implant margin and the muco-gingival junction. Mucosal thickness (MT) will be measured after topical application of the anesthetics. MT will be evaluated inserting a 27G needle with a rubber stop 1 mm below the peri-implant mucosal margin at the mid-buccal aspect, until the abutment is engaged. The needle will be removed and the distance between the rubber stop and the point of the needle will be measured with a manual periodontal probe.

Sponsors & Collaborators

  • Tufts University

    lead OTHER

Principal Investigators

  • Hans-Peter Weber · TUSDM

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-15
Primary Completion
2015-06-09
Completion
2015-06-09

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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 NCT03396536 on ClinicalTrials.gov