Periodontitis Clinical Trial
Official title:
The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Texas A&M School of Dentistry | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas A&M University | Institut Straumann AG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attachment level change. | 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. | The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination. | |
Primary | Probing depth change. | 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. | Probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up. | |
Primary | Gingival margin level / recession change. | 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. | Gingival margin level / recession level change will be determined from baseline to the 3 month follow-up and 6 month follow-up. | |
Primary | Bleeding on probing change. | 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. | The bleeding of probing change will be determined from the baseline to the 3 month follow-up and 6 month follow-up. | |
Primary | Biofilm presence change. | 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. | Biofilm presence change will be determined from the baseline to the 3 month follow-up and 6 month follow-up. | |
Secondary | Time necessary to perform the test procedures | Report the time necessary to perform the test procedures - non-incised minimally invasive flap procedure in conjunction with Emdogain. | 1 day (Time necessary to perform the test procedure at the initial appointment.) | |
Secondary | VAS pain scale 24 hours after appointment. | VAS pain scale for the test and control areas the following the procedure at 24 hours after appointment. The VAS scale is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS. | 24 hour follow-up. | |
Secondary | VAS pain scale 1 week after appointment. | VAS pain scale for the test and control areas 1 week following the procedure. The VAS scale is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS. | 1 week following the procedure. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04712630 -
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
|
N/A | |
Completed |
NCT06127069 -
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device
|
N/A | |
Completed |
NCT04964167 -
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
|
Phase 4 | |
Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
Recruiting |
NCT03997552 -
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
|
N/A | |
Completed |
NCT05530252 -
Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
|
Phase 4 | |
Completed |
NCT04881357 -
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
|
N/A | |
Recruiting |
NCT03790605 -
A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
|
Phase 3 | |
Enrolling by invitation |
NCT04971174 -
Outcomes of Periodontal Regenerative Treatment
|
||
Not yet recruiting |
NCT05568290 -
Interleukin-38 Levels in Individuals With Periodontitis
|
||
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Recruiting |
NCT03997578 -
Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects
|
N/A | |
Completed |
NCT03901066 -
Smoking Dependence and Periodontitis
|
||
Enrolling by invitation |
NCT04956211 -
Periodontal Treatment and Ischemic Stroke
|
N/A | |
Recruiting |
NCT05971706 -
Ozone Application in Periodontal Treatment
|
N/A | |
Recruiting |
NCT06099574 -
A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
|
||
Completed |
NCT04402996 -
Meteorin-like Levels in Individuals With Periodontitis
|
||
Active, not recruiting |
NCT05311657 -
Oral Health and Severe COPD
|
||
Not yet recruiting |
NCT06453278 -
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
|
||
Not yet recruiting |
NCT05643287 -
The Effect of Time on the Outcome of Periodontal Treatment.
|
N/A |