The Flapless Approach in Periodontal Regeneration

The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Intrabony Periodontal Defect; Periodontitis, Adult
• Intervention / Treatment: Procedure: Flapless with Enamel Matrix Derivatives (EMD); Procedure: Flapless without Enamel Matrix Derivatives (EMD)

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • CIR Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flapless with Enamel Matrix Derivatives (EMD); Closed non-surgical treatment of periodontal intrabony defects with the combined use of Enamel Matrix Derivatives (EMD).	Procedure: Flapless with Enamel Matrix Derivatives (EMD); 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.
Active Comparator: Flapless alone; Closed non-surgical treatment of periodontal intrabony defects without any adjunct.	Procedure: Flapless without Enamel Matrix Derivatives (EMD); 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. No adjunct will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	12 months

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Chronic Disease; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: EMDTurin1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No