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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05721313
• Other study ID #: COM
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Furcation Defects
• Periodontal Diseases

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