The Flapless Approach in Periodontal Regeneration

Not Applicable

Completed

• Conditions: Periodontitis, Adult; Intrabony Periodontal Defect
• Interventions: Procedure: Flapless with Enamel Matrix Derivatives (EMD); Procedure: Flapless without Enamel Matrix Derivatives (EMD)

• Registration Number: NCT05456555
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Study Start: 2022-09-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-15
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flapless with Enamel Matrix Derivatives (EMD)	Flapless with Enamel Matrix Derivatives (EMD)	Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD).
Flapless alone	Flapless without Enamel Matrix Derivatives (EMD)	Closed non-surgical treatment of periodontal intrabony defects without any adjunct.

Primary Outcome Measures

Name	Time	Method
Clinical attachment level change	12 months	Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Secondary Outcome Measures

Name	Time	Method
Radiographic bone level change	12 months	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)
Probing pocket depth change	12 months	Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy