NCT05456555

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-01
• Completion: 2023-12-15
• First posted: 2022-07-13
• Last updated: 2023-12-19

Locations

1 site across 1 country: Italy