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Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study

Primary Purpose

Periodontal Diseases, Furcation Defects

Status

Not yet recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

root resection

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontal disease, Furcation defects, Root resection

Eligibility Criteria

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Inclusion Criteria: Patient diagnosed with stage III-IV periodontitis Compliantpatient, as shown by full mouth plaque score<30% Previous non-surgical periodontal therapy within 6 mounths Maxillary or mandibular molar affected by periodontal furcation involvement and scheduled for root resection Positive to sensibility testing (cold/electric pulp tests) No prosthesis or large restorations Sufficiently divergent roots to make root resection feasible Root trunk lenght at 3 mm as measured in periapical radiograph Exclusion Criteria: Systemic contraindications to perform periodontal surgery/root resection Fused roots Presence of periapical radiolucency Furcation class III affecting all roots of maxillary molar

Sites / Locations

Centro Odontoiatrico Mediterraneo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with advanced periodontal furcation involvement

Arm Description

Outcomes

Primary Outcome Measures

Tooth vitality (positive response to cold test)

following the 3rd visit will be make a re-evaluation of the tooth vitality, by a positive response to cold test, every 3 month.

No periapical lesion

following the 3rd visit will be make a re-evaluation of the periapical heath condition, by a periapical rx, every year

Secondary Outcome Measures

Full Information

NCT ID

NCT05721313

First Posted

January 25, 2023

Last Updated

July 18, 2023

Sponsor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

1. Study Identification

Unique Protocol Identification Number

NCT05721313

Brief Title

Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study

Official Title

Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical trial is to test in 10 patients with advanced furcation involvement on molars. The main question[s] it aims to answer are: • Is it possible to carry out root resection without endodontic treatment on molars? Tooth vitality will be checked (positive response to cold test). Root resection will be carried out under local anestesia. Following visits will be carried out for re-evaluation/maintenance according to clinical care every 3 mounths until 3 years follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases, Furcation Defects

Keywords

Periodontal disease, Furcation defects, Root resection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot cohort study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with advanced periodontal furcation involvement

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

root resection

Intervention Description

It will be carried out under local anestesia. Intra-crevicular or para-marginal gingival incision will be carried out and full-tickness mucoperiostal flaps will be raised to expose the affected roots. Whit the use (if possible) of a surgical stent an incision will be performed on the root to be removed. Biodentine will be used for retrogade obturation. The flaps will be sutured.

Primary Outcome Measure Information:

Title

Tooth vitality (positive response to cold test)

Description

following the 3rd visit will be make a re-evaluation of the tooth vitality, by a positive response to cold test, every 3 month.

Time Frame

3-year follow-up

Title

No periapical lesion

Description

following the 3rd visit will be make a re-evaluation of the periapical heath condition, by a periapical rx, every year

Time Frame

3-year follow-up

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Centro Odontoiatrico Mediterraneo

City

Catania

State/Province

ZIP/Postal Code

95128

Country

Italy

12. IPD Sharing Statement

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Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study

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