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The Flapless Approach in Periodontal Regeneration

NCT05456555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-12-19

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-12-01
Completion
2023-12-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456555 on ClinicalTrials.gov