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Minimally Invasive Gum Disease Treatment with Emdogain® MI

This study is comparing two ways to treat gum disease (periodontitis) and attachment loss. One method uses a minimally invasive procedure with a videoscope to clean tooth roots, along with a product called Emdogain® MI. The other method uses the same minimally invasive procedure and videoscope but without Emdogain® MI. Researchers want to see if Emdogain® MI helps improve attachment levels, probing depth, and gum recession. You may be able to join if you are between 30 and 75 years old, have generalized gum disease with specific pocket depths, and at least 2mm of attachment loss. The study aims to enroll 32 participants.

Study design
This interventional study plans to enroll 32 participants to compare two treatment approaches for gum disease.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your attachment level, probing depth, and gum margin will be measured at 3 months and 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05964699

The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP

Recruiting
NAAges 30–75InterventionalTreatment
Texas A&M University
~32 participants
Updated 2024-08-21 on ClinicalTrials.gov
What's tested:Minimally invasive periodontal therapy with use of EmdogainMinimally invasive periodontal therapy without the use of Emdogain

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Attachment level change.
Measured over The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination.
+4 more outcomes measured

Conditions

Periodontitis
Attachment Loss, Periodontal

Explore related trials

Periodontitis

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Daniel Patrick O Ryan, DDS
[email protected]
2143642857
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Attachment level change.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.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.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.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.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.