Emdogain Minimally Invasive Surgical Technique

Straumann

Status

Completed

Conditions

Periodontitis

Treatments

Device: Emdogain application

Procedure: Scaling and root planing without Emdogain

Procedure: Scaling and root planing

Study type

Interventional

Funder types

Industry

Identifiers

NCT02551770

CR 01/15

Details and patient eligibility

About

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).

Full 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.

Enrollment

51 patients

Sex

All

Ages

21 to 85 years old

Volunteers

Accepts Healthy Volunteers

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