The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorTexas A&M University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
You are pregnant.
You are breast feeding.
Received gum treatment in the last 6 months.
Smoke more than ten cigarettes per day.
Trial design
Design model
Parallel
Treatments tested in this trial
Minimally invasive periodontal therapy with use of Emdogain
Procedure/SurgeryScaling of root with assisted use of the Videoscope and regrowth of attachment by the use of Emdogain.
Minimally invasive periodontal therapy without the use of Emdogain
Procedure/SurgeryScaling of root with assisted use of the Videoscope.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Periodontal regenerationExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination.2
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.
Time frame
Probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.3
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.
Time frame
Gingival margin level / recession level change will be determined from baseline to the 3 month follow-up and 6 month follow-up.4
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.
Time frame
The bleeding of probing change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.Secondary outcomes
1
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.
Time frame
1 day (Time necessary to perform the test procedure at the initial appointment.)2
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.
Time frame
24 hour follow-up.3
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.
Time frame
1 week following the procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas A&M University
Lead sponsor
Institut Straumann AG
Collaborator
Source ClinicalTrials.gov