- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05721313
Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
CT
-
Catania, CT, Italy, 95128
- Centro Odontoiatrico Mediterraneo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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