ClinicalTrials.gg
Not yet recruitingNCT05721313Updated Jul 19, 2023

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

An interventional study of root resection in Periodontal Diseases and Furcation Defects, sponsored by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele. Not yet recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-07-19.

Primary conditionFurcation DefectsRegistry: Periodontal DiseasesReclassifiedWhy we changed it
Registry
Periodontal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Furcation Defects
Why
  1. The study's listed conditions name Furcation Defects, a narrower term within Periodontal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontal Diseases
  • Furcation Defects

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Keywords

  • Periodontal disease
  • Furcation defects
  • Root resection
03

In context

Furcation Defects Reclassified

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's planned enrollment of 10 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Compared within Furcation Defects, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Systemic to perform periodontal surgery/root resection
  • Fused roots
  • Presence of periapical radiolucency
  • Furcation class III affecting all roots of maxillary molar
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Patients with advanced periodontal furcation involvement

    Procedure: root resection

Interventions

  • Procedureroot 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3-year follow-up

  2. No periapical lesion

    following the 3rd visit will be make a re-evaluation of the periapical heath condition, by a periapical rx, every year

    Time frame: 3-year follow-up

07

Study locations

1 site
  • Centro Odontoiatrico Mediterraneo
    Catania, CT 95128, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2023; primary completion for Jan 2024, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2023
First posted
Feb 10, 2023
StartEst.
Sep 1, 2023
Primary completionEst.
Jan 1, 2024
CompletionEst.
Jan 15, 2025
Last update
Jul 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05721313
Lead sponsor
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Responsible party
Giovanni Barbagallo (DDS, DMD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele) — Principal investigator
First posted
Feb 10, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Jan 15, 2025 (estimated)
Last update
Jul 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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