CompletedPhase 4

Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation

United States56 participantsStarted 2020-02-14

Plain-language summary

The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT samples.

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

. Red, swollen gingival tissues surrounding the implant
. Presence of bleeding and/or suppuration on gentle probing around the implant
. Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
. May or may not have progressive bone loss in relation to radiographic bone levels assessed either 1 year following restoration of the implant OR ≥3mm of radiographic bone loss from the implant platform -systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

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

Mean Probing Pocket Depth

Timeframe: Baseline

Mean Probing Pocket Depth

Timeframe: 6 weeks post treatment

Mean Probing Pocket Depth

Timeframe: 12 weeks post treatment

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Timeframe: Baseline

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Timeframe: 6 weeks post treatment

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Timeframe: 12 weeks post treatment

Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing

Timeframe: Baseline

Trial details

NCT IDNCT04187053

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-06

Results submitted2023-12-05

View on ClinicalTrials.gov More DENT IMPLANTS trials

Plain-language summary

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

. Red, swollen gingival tissues surrounding the implant
. Presence of bleeding and/or suppuration on gentle probing around the implant
. Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
. May or may not have progressive bone loss in relation to radiographic bone levels assessed either 1 year following restoration of the implant OR ≥3mm of radiographic bone loss from the implant platform -systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

What they're measuring

Mean Probing Pocket Depth

Timeframe: Baseline

Mean Probing Pocket Depth

Timeframe: 6 weeks post treatment

Mean Probing Pocket Depth

Timeframe: 12 weeks post treatment

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Timeframe: Baseline

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Timeframe: 6 weeks post treatment

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Timeframe: 12 weeks post treatment

Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing

Timeframe: Baseline