The Flapless Approach in Periodontal Regeneration

NCT05456555 | Completed

• 1 other identifier: EMDTurin1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Adult; Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Radiographic bone level change

  12 months

• Probing pocket depth change

  12 months

Study Arms (2)

Flapless with Enamel Matrix Derivatives (EMD)

EXPERIMENTAL

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

Procedure: Flapless with Enamel Matrix Derivatives (EMD)

Flapless alone

ACTIVE COMPARATOR

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

Procedure: Flapless without Enamel Matrix Derivatives (EMD)

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 with Enamel Matrix Derivatives (EMD)

Flapless without 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. No adjunct will be administered.

Flapless alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

Location

Related Publications (1)

• Aimetti M, Stasikelyte M, Mariani GM, Cricenti L, Baima G, Romano F. The flapless approach with and without enamel matrix derivatives for the treatment of intrabony defects: A randomized controlled clinical trial. J Clin Periodontol. 2024 Sep;51(9):1112-1121. doi: 10.1111/jcpe.14028. Epub 2024 Jun 10.

  PMID: 38859627 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 15, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)