The Flapless Approach in Periodontal Regeneration

University of Turin, Italy46 enrolled

Overview

The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periodontitis, Adult Intrabony Periodontal Defect

Interventions

Flapless with Enamel Matrix Derivatives (EMD)PROCEDURE

Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface.

Flapless without Enamel Matrix Derivatives (EMD)PROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of periodontitis stage III or IV; * presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy; * a full-mouth plaque score and full-mouth bleeding score \<15% at the time of the experimental procedure; * signed informed consent. Exclusion Criteria: * relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing; * consumption of drugs known to affect periodontal status; * pregnancy and lactation; * third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration; * heavy smokers \>10 cigarettes per day.

Locations (1)

CIR Dental School

Turin, Italy

Outcomes

Primary Outcomes

Clinical attachment level change

Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Time frame: 12 months

Secondary Outcomes

Radiographic bone level change

Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)

Time frame: 12 months

Probing pocket depth change

Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Time frame: 12 months

Data from ClinicalTrials.gov

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