Periodontal DiseasesNCT05721313
Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study
A study testing root resection in people with Periodontal Diseases and Furcation Defects, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Furcation Defects
- What is being tested?
- root resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Systemic contraindications to perform periodontal surgery/root resection
- Fused roots
- Presence of periapical radiolucency
- Furcation class III affecting all roots of maxillary molar
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Periodontal Diseases, Furcation Defects
- Being tested
- root resection
- Keywords
- Periodontal disease, Furcation defects, Root resection
- Medical subject headings
- Periodontal Diseases, Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root resectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced periodontal furcation involvement | Experimental | Not described Receives: Procedure: root resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot cohort study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Barbagallo, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721313
- Sponsor's protocol ID
- COM
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study
- ClinicalTrials.gov ID
- NCT05721313
- Acronym / sponsor ID
- COM
- Conditions
- Periodontal Diseases, Furcation Defects
- Keywords
- Periodontal disease, Furcation defects, Root resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio EmanueleUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot cohort study
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced periodontal furcation involvement | Experimental | Procedure: root resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- Systemic contraindications to perform periodontal surgery/root resection
- Fused roots
- Presence of periapical radiolucency
- Furcation class III affecting all roots of maxillary molar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| root resectionIt 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. | Procedure or surgery | Patients with advanced periodontal furcation involvement |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root resection in people with Periodontal Diseases and Furcation Defects, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth vitality (positive response to cold test) (time frame: 3-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.