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

NCT ID: NCT05721313

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Diseases Furcation Defects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with advanced periodontal furcation involvement

Group Type EXPERIMENTAL

root resection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Barbagallo

DDS, DMD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro Odontoiatrico Mediterraneo

Catania, CT, Italy

Site Status

Countries

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Italy

Other Identifiers

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COM

Identifier Type: -

Identifier Source: org_study_id

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