Flapless Approach for the Treatment of Intrabony Defects

NCT05354037 | Unknown DMC

• 1 other identifier: FLPERIO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• Difference in CAL between baseline and 1-year follow-up

  The difference between CAL values at baseline and after 1 year; CAL is defined as the distance between CEJ and the most apical extent of the pocket / sulcus

  1 year

Secondary Outcomes (8)

• Difference in PD between baseline and 1-year follow-up

  1 year

• Difference in REC between baseline and 1-year follow-up

  1 year

• Difference in PI between baseline and 1-year follow-up

  1 year

• Difference in BI between baseline and 1-year follow-up

  1 year

• Difference in FMBS% between baseline and 1-year follow-up

  1 year

Study Arms (2)

Group A

ACTIVE COMPARATOR

EMD + M-MIST approach

Procedure: Enamel matrix derivative application for treatment of intrabony defects

Group B

EXPERIMENTAL

EMD with flapless approach

Procedure: Enamel matrix derivative application for treatment of intrabony defects

Interventions

Enamel matrix derivative application for treatment of intrabony defects PROCEDURE

EMD application will be associated to M-MIST approach in control group and flapless approach in test group.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over or equal to the age of 18 years
• Patients who are able to understand the requirements of the study and are willing and able to comply with its instructions and schedules
• Patients who had provided written informed consent to participate in the study prior to any study procedure
• Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (American Society of Anesthesiologists ASA 1 or ASA-2)
• Patients having one or more self-contained (3-wall or 2-3 walls) intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation.

You may not qualify if:

• FMPS% \> 15%
• FMBS% \> 15%
• Treatment with anticoagulant drugs (International Normalized Ratio (INR) above 2,5)
• Treatment with intravenous bisphosphonates
• Treatment with anticonvulsants drugs
• untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements
• Patients with history of alcohol, narcotics or drug abuse
• Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years
• Patients through at any time received radiotherapy to the head and neck region will be excluded anyway
• Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
• Degenerative diseases
• Osteoradionecrosis
• Renal failure
• Organ transplant recipients
• HIV positive (self-declaration)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Study Officials

• Stefano Corbella

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Corbella, DDS, PhD

CONTACT

02 50319950; stefano.corbella@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: April 29, 2022
• Study Start: May 13, 2021
• Primary Completion: December 30, 2022
• Study Completion: April 30, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

IT (1)