The Flapless Approach in Periodontal Regeneration

University of Turin

Status: Completed

Conditions: Intrabony Periodontal Defect; Periodontitis, Adult

Treatments: Procedure: Flapless with Enamel Matrix Derivatives (EMD); Procedure: Flapless without Enamel Matrix Derivatives (EMD)

Study type: Interventional

Funder types: Other

Identifiers

NCT05456555

EMDTurin1

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Flapless with Enamel Matrix Derivatives (EMD)

Experimental group

Description:

Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD).

Treatment:

Procedure: Flapless with Enamel Matrix Derivatives (EMD)

Flapless alone

Active Comparator group

Description:

Closed non-surgical treatment of periodontal intrabony defects without any adjunct.

Treatment:

Procedure: Flapless without Enamel Matrix Derivatives (EMD)