Your session is about to expire
← Back to Search
Procedure
aPDT + Mechanical Debridement for Gum Disease
N/A
Recruiting
Led By Shreena P Bhakta, DDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No furcation involvement
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
Awards & highlights
Study Summary
This trial is studying whether using a light therapy along with mechanical debridement can improve outcomes for people with plaque-induced inflammation.
Who is the study for?
This trial is for individuals with gum disease who have at least one tooth on each side of their mouth with a pocket depth greater than 4mm and bleeding upon probing. They must not be heavy smokers, pregnant, or have uncontrolled diabetes or other systemic diseases that affect healing.Check my eligibility
What is being tested?
The study is examining the effectiveness of Antimicrobial photodynamic therapy (aPDT) as an addition to mechanical debridement in treating teeth affected by periodontal disease. It will also assess changes in the microbiologic profile of these sites before and after treatment.See study design
What are the potential side effects?
While specific side effects are not listed, aPDT generally has minimal side effects which may include slight discomfort during treatment and temporary sensitivity or irritation in the treated area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My gums do not have any areas where the roots of my teeth split.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in number of bleeding sites (Bleeding On Probing)
Change in probing depth (Periodontal pocket depth )
Secondary outcome measures
change in microbiologic profile of gingival crevicular fluid(GCF)
change in microbiologic profile of plaque
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: mechanical debridement and adjunctive aPDTExperimental Treatment2 Interventions
Group II: mechanical debridement and sham aPDTActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mechanical debridement
2021
N/A
~70
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,940 Total Patients Enrolled
Shreena P Bhakta, DDSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled diseases like Vitamin C deficiency or immune disorders.I smoke more than 10 cigarettes a day.My gums do not have any areas where the roots of my teeth split.I need surgery to fix bone loss in my jaw.You need to have a pocket on both sides of your mouth for the study.I have a tooth with only one root.I have taken antibiotics within the last 3 months.My diabetes is not under control (HbA1c is 6.5% or higher).
Research Study Groups:
This trial has the following groups:- Group 1: mechanical debridement and adjunctive aPDT
- Group 2: mechanical debridement and sham aPDT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitments still open for this experimental trial?
"According to the most recent information on clinicaltrials.gov, this medical trial is currently enrolling participants; it was initially published on April 26th 2022 and had a substantial update in October of that same year."
Answered by AI
How many participants are eligible for the research project?
"Affirmative. The clinicaltrials.gov website reveals that this medical experiment, which was initially posted on April 26th 2022 is still recruiting participants. A total of 20 people need to be recruited from a single site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger