NCT05964699 The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP
| NCT ID | NCT05964699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Texas A&M University |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2023-07-31 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2023-07-31 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to evaluate the use of Emdogain® MI in a procedure where a significant portion of the lining of the sulcus is removed by curettage (similar to the traditional clinical procedure described as "gingival curettage") to the point of tissue mobility. This will be designated as a "non-incised minimally invasive flap access procedure". A videoscope will be utilized to assist with the requirement to adequately visualize and debride the root surface. This research project will define the approach used as a "non-incised minimally invasive flap access" approach and will be a modification of recognized minimally invasive techniques. This modification will be made by Dr. Harrel who first describe the minimally invasive periodontal approach and defined minimally invasive periodontal procedures in 1995.
Eligibility Criteria
Inclusion Criteria: To participate in this study, you must present: * Generalized gum disease with isolated pocket depths of 5 mm to less than 7 mm on bicuspid and cuspid teeth. * At least 2 mm of attachment loss. * Need to have two similar teeth meeting the criteria for isolated pockets on two other quadrants of the mouth. * Need to be between 30 and 75 years of age. * Be in good health. * Smoke less than 10 cigarettes or equivalent per day. * No antibiotics for the past 90 days. * Not be taking medications that are known to inhibit or slow healing. Exclusion Criteria: You are not eligible if: * You are pregnant. * You are breast feeding. * Received gum treatment in the last 6 months. * Smoke more than ten cigarettes per day. * You have any serious medical conditions.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05964699 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05964699 currently recruiting?
Yes, NCT05964699 is actively recruiting participants. Contact the research team at dryan@tamu.edu for enrollment information.
Where is the NCT05964699 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT05964699 clinical trial?
NCT05964699 is sponsored by Texas A&M University. The trial plans to enroll 32 participants.