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

NCT05721313 | Unknown

• 1 other identifier: COM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Furcation Defects

Keywords

Periodontal disease; Furcation defects; Root resection

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients with advanced periodontal furcation involvement

EXPERIMENTAL

Procedure: root resection

Interventions

root resection 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.

Patients with advanced periodontal furcation involvement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Systemic contraindications to perform periodontal surgery/root resection
• Fused roots
• Presence of periapical radiolucency
• Furcation class III affecting all roots of maxillary molar

Sponsors & Collaborators

• Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele: lead

Study Sites (1)

Centro Odontoiatrico Mediterraneo

Catania, CT, 95128, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases; Furcation Defects

Interventions

Apicoectomy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, DMD

Model Details: Pilot cohort study

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 10, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 15, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

IT (1)