The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Texas A&M University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Attachment level change.
Study Overview
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.
Detailed Description
The use of a non-incised minimally invasive flap procedure in conjunction with Emdogain MI compared to traditional scaling and root planing.
Background
The product Emdogain® MI is designed for use in a minimally invasive approach to periodontal treatment. This product is being marketed for what is termed a "flapless" procedure whereby scaling and root planing (SRP) is performed, the root surface is "visualized", debrided, and conditioned with EDTA (PrefGel), and then Emdogain® MI is inserted between the root surface and the sulcus tissue to reduce inflammation and stimulate reattachment.
The approach described above has met with mixed success. The concerns are associated with difficulty in the visualization of the sulcus and the difficulty in removing root accretions (calculus) with the "flapless" approach.
Purpose
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, investigators, and outcome assessors are unaware of the assigned interventions. The care provider will know at this time of procedure what site will receive the intervention and what site will be the control site.
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Periodontal regeneration
Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.
Intervention: Minimally invasive periodontal therapy with use of Emdogain (Procedure)
Control
The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.
Intervention: Minimally invasive periodontal therapy without the use of Emdogain (Procedure)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Time necessary to perform the test procedures(1 day (Time necessary to perform the test procedure at the initial appointment.))
- VAS pain scale 1 week after appointment.(1 week following the procedure.)
- VAS pain scale 24 hours after appointment.(24 hour follow-up.)