The Flapless Approach in Periodontal Regeneration

Intrabony Periodontal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456555
• Other study ID #: EMDTurin1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 15, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Intrabony Periodontal Defect
• Periodontitis
• Periodontitis, Adult

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	CIR Dental School	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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