Emdogain Minimally Invasive Surgical Technique

NCT02551770 | Completed Results

• 1 other identifier: CR 01/15
• Study Type: interventional
• Target: 51
• Locations: 3 countries
• Sites: 4

Brief Summary

The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Levels (CAL)

  CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.

  Baseline and 12 Month Follow-Up Visit

Secondary Outcomes (6)

• Change in Gingival Margin (GM)

  Baseline and 12 Month Follow-Up Visit

• Change in Pocket Probing Depth (PPD)

  Baseline and 12 Month Follow-Up Visit

• Change in Full Mouth Plaque Score (FMPS)

  Baseline and 12 Month Follow-Up Visit

• Change in Bleeding on Probing (BoP)

  Baseline and 12 Month Follow-Up Visit

• Change in Root Dentin Hypersensitivity

  Baseline and 12 Month Follow-Up Visit

Study Arms (2)

Test (with Emdogain)

ACTIVE COMPARATOR

Scaling and root planing with Emdogain

Procedure: Scaling and root planing; Device: Emdogain application

Control (without Emdogain)

OTHER

Scaling and root planing without Emdogain

Procedure: Scaling and root planing without Emdogain

Interventions

Scaling and root planing PROCEDURE

Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.

Test (with Emdogain)

Scaling and root planing without Emdogain PROCEDURE

Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.

Control (without Emdogain)

Emdogain application DEVICE

Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw

Test (with Emdogain)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have voluntarily signed the informed consent form before any study related procedures
• Subjects must be males or females who are 18-85 years of age
• Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth)
• Subjects must be committed to the study and the required follow-up visits
• Subjects must be in good general health as assessed by the Investigator

You may not qualify if:

• Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation
• Subjects who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day) or who use chewing tobacco
• Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study
• Subjects with uncontrolled diabetes
• Subjects that are immunocompromised or immunosuppressed
• Subjects that cannot provide informed consent
• Subjects with drug or alcohol abuse
• Subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months
• Subjects that are pregnant
• Subjects with necrotizing periodontitis or periodontitis related to systemic disease
• Teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth
• Teeth with pockets or defects with furcation involvement will not classify as study teeth
• Teeth with mobility degree \> 1 without splint will not classify as study teeth
• Subjects with test and control sites in the two quadrants on adjacent teeth
• Patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (4)

Periodontal and Implant Associates, Inc.

Cullman, Alabama, 35055, United States

Location

Periodontics and Implant Dentistry

Aurora, Colorado, 80012-3202, United States

Location

Clinique Paro Excellence

Montreal, Quebec, H3B 3A7, Canada

Location

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing; enamel matrix proteins

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Results Point of Contact

• Title: Dr. Manfred Klasser
• Organization: GWD Consult

manfred.klasser@gwd-consult.de

+49 6108 825 65 20

Study Officials

• Pamela K McClain, DDS

  Periodontics and Implant Dentistry

  PRINCIPAL INVESTIGATOR

• Veronique Benhamou, DDS

  Clinique Paro Excellence

  PRINCIPAL INVESTIGATOR

• Jennifer H Doobrow, DMD

  Periodontal & Implant Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 16, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: August 30, 2019
• Last Updated: October 17, 2019
• Results First Posted: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1); DE (1)