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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05721313
Other study ID # COM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date January 15, 2025

Study information

Verified date July 2023
Source Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date January 15, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Centro Odontoiatrico Mediterraneo Catania CT

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3-year follow-up
Primary No periapical lesion 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
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