NCT05964699 · Texas A&M University
The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP
What this study is about
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".
View original scientific description
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.
Interventions
PROCEDURE
Minimally invasive periodontal therapy with use of Emdogain
Scaling of root with assisted use of the Videoscope and regrowth of attachment by the use of Emdogain.
PROCEDURE
Minimally invasive periodontal therapy without the use of Emdogain
Scaling of root with assisted use of the Videoscope.
Primary outcome measures
Attachment level change.
Time frame: The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination.
Attachment change will be determined by measuring clinical probing depth and gingival marginal level with an UNC probe. The clinical attachment level is the distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement.
Probing depth change.
Time frame: Probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
Probing depth change will be determined with an UNC probe during clinical examination on the control and test sites. Probing depth will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Probing depth is the distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe.
Gingival margin level / recession change.
Time frame: Gingival margin level / recession level change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
Gingival margin level / recession will be determined with an UNC probe during clinical examination on the control and test sites. Gingival margin level / recession will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. The migration of the marginal soft tissue to a point apical to the cemento-enamel junction of a tooth or the platform of a dental implant is defined as recession.
Bleeding on probing change.
Time frame: The bleeding of probing change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.
Bleeding on probing will be determined with an UNC probe during clinical examination on the control and test sites. Bleeding of probing sites will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Bleeding on probing happens when induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
Biofilm presence change.
Time frame: Biofilm presence change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.
Biofilm presence will be determined with an UNC probe during clinical examination on the control and test sites. Biofilm will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Dental plaque is the prototypical example of a biofilm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Dallas, Texas
Collaborators
Institut Straumann AG
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2024 · Source of record for eligibility and locations