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

NCT05964699 | Recruiting DMC

• 1 other identifier: IRB2022-1175-CD-DCR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Attachment Loss, Periodontal

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Time necessary to perform the test procedures

  1 day (Time necessary to perform the test procedure at the initial appointment.)

• VAS pain scale 24 hours after appointment.

  24 hour follow-up.

• VAS pain scale 1 week after appointment.

  1 week following the procedure.

Study Arms (2)

Periodontal regeneration

EXPERIMENTAL

Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.

Procedure: Minimally invasive periodontal therapy with use of Emdogain

Control

PLACEBO COMPARATOR

The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.

Procedure: Minimally invasive periodontal therapy without the use of Emdogain

Interventions

Minimally invasive periodontal therapy with use of Emdogain PROCEDURE

Scaling of root with assisted use of the Videoscope and regrowth of attachment by the use of Emdogain.

Periodontal regeneration

Minimally invasive periodontal therapy without the use of Emdogain PROCEDURE

Scaling of root with assisted use of the Videoscope.

Control

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas A&M University: lead
• Institut Straumann AG: collaborator

Study Sites (1)

Texas A&M School of Dentistry

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Daniel Patrick O Ryan, DDS

CONTACT

2143642857; dryan@tamu.edu

Carlos Parra, DDS

CONTACT

6179716788; cparra@tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth study

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 28, 2023
• Study Start: July 31, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)