Emdogain Minimally Invasive Surgical Technique

NCT ID: NCT02551770

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-08-30

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).

Detailed Description

The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test (with Emdogain)

Scaling and root planing with Emdogain

Group Type: ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type: PROCEDURE

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

Emdogain application

Intervention Type: DEVICE

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

Control (without Emdogain)

Scaling and root planing without Emdogain

Group Type: OTHER

Scaling and root planing without Emdogain

Intervention Type: PROCEDURE

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

Interventions

Scaling and root planing

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

Intervention Type: PROCEDURE

Scaling and root planing without Emdogain

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

Intervention Type: PROCEDURE

Emdogain application

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subjects with conditions or circumstances, in the opinion of the Investigator , which would prevent completion of study participation or interfere with analysis of study results

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela K McClain, DDS

Role: PRINCIPAL_INVESTIGATOR

Periodontics and Implant Dentistry

Veronique Benhamou, DDS

Role: PRINCIPAL_INVESTIGATOR

Clinique Paro Excellence

Jennifer H Doobrow, DMD

Role: PRINCIPAL_INVESTIGATOR

Periodontal & Implant Associates

Locations

Periodontal and Implant Associates, Inc.

Cullman, Alabama, United States

Periodontics and Implant Dentistry

Aurora, Colorado, United States

Clinique Paro Excellence

Montreal, Quebec, Canada

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, , Germany

Countries

United States; Canada; Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR 01/15

Identifier Type: -

Identifier Source: org_study_id