NCT05354037

Flapless Approach for the Treatment of Intrabony Defects

Flapless Approach for the Treatment of Self-contained Intrabony Defects: a Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The use of Enamel Matrix Derivative (EMD) associated to microsurgical flaps was demonstrated to be effective for the treatment of intrabony defects, in particular in presence of a self-contained anatomy. The main aim of this study will be to evaluate the difference in Clinical Attachment Level (CAL) between baseline and 1-year follow-up, comparing flapless periodontal regeneration using EMD versus the use of EMD after microsurgical flap elevation (Modified-Minimally Invasive Surgical Technique (M-MIST) / Single-flap approach).

Detailed description

The secondary aims of the study are: * to evaluate the comparative effectiveness of the proposed treatment evaluating patient-centered outcomes. * to evaluate, after one year from the treatment, the comparative effectiveness evaluating clinical parameters: (I) Probing Depth (PD) measured from the gingival margin to the base of the pocket; (II) Recession (REC) measured as the distance between the CEJ and the gingival margin; (III) Presence of plaque in the site of intervention, measured dichotomously (Yes / No) (Plaque index (PI)); (IV) Presence of bleeding in the site of intervention, measured dichotomously (Yes / No) (Bleeding Index (BI)); (V) Full-mouth Bleeding Score (FMBS%); (VI) Full-mouth Plaque Score (FMPS%); (VII) the proportion of treated sites for each group that presented PD \<= 3 mm. ; (VIII) tooth retention * to evaluate the comparative effectiveness evaluating radiographic parameters: (I) The distance between the Cemento-Enamel Junction (CEJ) and the bottom of the defect (CEJ-A) (II) the distance between the projection of the bone crest to the root surface and the bottom of the defect (representing the intrabony portion of the defect (III) C-A), and the distance between the bone crest and the root surface (representing the maximum width of the defect, C-B) were measured. Control group: A buccal flap extending to the surfaces of the adjacent teeth will be elevated leading the interdental papilla in position following the M-MIST approach. After degranulation of the defect EMD will be applied following the standard procedure (after preparing root surface with Ethylenediamine tetraacetic acid (EDTA) 22% for two minutes). Non-resorbable 6/0 sutures will be used. The whole procedure will be performed using magnification devices (surgical loupes or surgical microscope). The operator will give postoperative instructions and information about medication. Test group: The debridement of the pocket will be performed without the elevation of the flap, using ultrasonic tips, air polishing devices and curettes as standard procedure. After that, EMD will be applied and the same procedures as control group will be carried out. Non-resorbable 6/0 sutures will be used in the site of surgical intervention to close coronally the pocket. At 7 days, suture removal, collection of questionnaires and clinical evaluation will be performed. Follow-up visits will be carried out at 3, 6, 12, 18 and 24 months.

Conditions

• Intrabony Periodontal Defect

Interventions

Type	Name	Description
PROCEDURE	Enamel matrix derivative application for treatment of intrabony defects	EMD application will be associated to M-MIST approach in control group and flapless approach in test group.

Timeline

• Start date: 2021-05-13
• Primary completion: 2022-12-30
• Completion: 2023-04-30
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: Italy