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Minimally Invasive Flap Procedure + Emdogain for Gum Disease

N/A
Recruiting
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
Awards & highlights

Study Summary

This trial studies a modified approach to a minimally invasive periodontal procedure, using a videoscope to better view and debride root surfaces. The goal is to improve the traditional "gingival curettage" technique.

Who is the study for?
This trial is for adults aged 30-75 with moderate gum disease, specifically isolated pocket depths of 5-7 mm on certain teeth and at least 2 mm of attachment loss. Participants should be in good health, not have had antibiotics or gum treatments recently, smoke less than 10 cigarettes a day, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests a minimally invasive flap procedure to treat gum disease using Emdogain® MI versus the same procedure without Emdogain. It involves removing part of the sulcus lining and cleaning the root surface with visual aid from a videoscope.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, swelling or bruising of gums, infection risk due to curettage, and possible allergic reactions to Emdogain if used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attachment level change.
Biofilm presence change.
Bleeding on probing change.
+2 more
Secondary outcome measures
Time necessary to perform the test procedures
VAS pain scale 1 week after appointment.
VAS pain scale 24 hours after appointment.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Periodontal regenerationExperimental Treatment1 Intervention
Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.
Group II: ControlPlacebo Group1 Intervention
The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
140 Previous Clinical Trials
24,074 Total Patients Enrolled
1 Trials studying Periodontal Attachment Loss
20 Patients Enrolled for Periodontal Attachment Loss
Institut Straumann AGIndustry Sponsor
52 Previous Clinical Trials
2,607 Total Patients Enrolled
1 Trials studying Periodontal Attachment Loss
35 Patients Enrolled for Periodontal Attachment Loss

Media Library

Periodontal regeneration Clinical Trial Eligibility Overview. Trial Name: NCT05964699 — N/A
Periodontal Attachment Loss Research Study Groups: Periodontal regeneration, Control
Periodontal Attachment Loss Clinical Trial 2023: Periodontal regeneration Highlights & Side Effects. Trial Name: NCT05964699 — N/A
Periodontal regeneration 2023 Treatment Timeline for Medical Study. Trial Name: NCT05964699 — N/A
Periodontal Attachment Loss Patient Testimony for trial: Trial Name: NCT05964699 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do those over 45 years of age qualify to participate in this clinical trial?

"According to the qualifications for this study, only individuals aged between 30 and 75 are eligible to participate."

Answered by AI

Who is eligible to take part in this experimental research?

"Those wishing to take part in this trial must possess a diagnosis of periodontitis and be within the age group of 30 - 75. This study is targeting 32 participants."

Answered by AI

How many individuals have opted to participate in this clinical research?

"Affirmative, the documentation hosted on clinicaltrials.gov states that this medical examination is actively seeking out participants. This trial was first posted at the end of July 2023 and recently updated in late July 2023; they need to recruit 32 patients from 1 centre."

Answered by AI

Are participants still being recruited for this experiment?

"According to the clinicaltrials.gov's records, this trial is actively enrolling patients. Initial posting was on July 31st 2023 and the details were recently amended on July 26th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
Texas A&M School of Dentistry
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm hoping the clinical try will help in different ways to address my periodontal issues that I have been dealing with.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does the screening process take? What do you need from me?
PatientReceived 2+ prior treatments
~8 spots leftby Jul 2024