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

July 18, 2023 updated by: Giovanni Barbagallo, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CT
      • Catania, CT, Italy, 95128
        • Centro Odontoiatrico Mediterraneo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with advanced periodontal furcation involvement
Procedure: root resection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth vitality (positive response to cold test)
Time Frame: 3-year follow-up
following the 3rd visit will be make a re-evaluation of the tooth vitality, by a positive response to cold test, every 3 month.
3-year follow-up
No periapical lesion
Time Frame: 3-year follow-up
following the 3rd visit will be make a re-evaluation of the periapical heath condition, by a periapical rx, every year
3-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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