CompletedNot Applicable

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

43 participantsStarted 2014-01-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients 18 years of age or older * Patients treatment planned for second stage implant surgery (having already had stage one completed * Partially or fully edentulous patients that have a single implant or have multiple implants that are non-adjacent * Patients that have implant(s) that will be restored with fixed cement- or screw-retained restoration(s) Exclusion Criteria: * Unwilling to sign informed consent form * Non-English speaking subjects * Pregnant women (self-reported) * Heavy smokers (10 cigarettes/day) * Known allergy to iodine and/or potassium iodide (ingredients of Lugol's solution)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Discomfort

Timeframe: Change in patient discomfort at 3 months

Patient Discomfort

Timeframe: Change in patient discomfort at 6 months

Trial details

NCT IDNCT03396536

SponsorTufts University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-06-09

View on ClinicalTrials.gov More Keratinized Mucosa trials