Periodontal DiseasesNCT06520137
Third Molars Extraction and Periodontal Disease
An observational study of Periodontal Diseases, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the changes in periodontal conditions on the distal aspect of the second maxillary molar after the extraction of the maxillary wisdom tooth. As secondary outcome patient- related and tooth-related factors will be analysed to evaluate their effects on the periodontal varibales during… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Tooth extraction
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2024to 15 Sep 2026
- Phase
- Observational
- 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 19 to 64 years
- All sexes
- Adult
Study population: Hospital population.
Who may be able to join
- Age more than 18 years or older
- Presence of an impacted upper wisdom tooth that need to undergo surgical extraction
- Participants need to be able to sign and understand the informed consent and to follow the study-related procedures.
Who cannot join
- People that have compromised general health conditions (ASA 3, 4, 5, 6)
- Patients that assumed antibiotics in the last 6 months
- Pregnant or breastfeeding women
- Patients who suffer from periodontitis stage III and IV
- Presence of a third molar with incomplete root formation is not taken into account for the surgical extraction.
- Smoker patients
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Siena
Siena, Italy/SI, 53100
Simone Grandini, + 39 3357045335, grandini@unisi.it
About this study
Official title: Correlation Between Upper Third Molars Extraction and Upper Second Molars Periodontal Disease: a Prospective Clinical Observational Study
The aim of the study is to evaluate the changes in periodontal conditions on the distal aspect of the second maxillary molar after the extraction of the maxillary wisdom tooth. As secondary outcome patient- related and tooth-related factors will be analysed to evaluate their effects on the periodontal varibales during time.
- Conditions
- Periodontal Diseases
- Being tested
- Tooth extraction
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extractionProcedure or surgery
Extraction of maxillary third molars
| Study group | Role | What they receive |
|---|---|---|
| Group A with PPD ≤ 3 mm | Not described Receives: Procedure: Tooth extraction | |
| Group B with PPD ≥ 4 mm | Not described Receives: Procedure: Tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pockeet Depth (PPD)
Distance between the free gingival margin and the apical location of the probe's tip.
Measured: Baseline, 1 month, 6 months, 12 months, 24 months
Bone Level (BL)
Distance between the bone crest and the cemento-enamel junction (CEJ)
Measured: Baseline, 1 month, 6 months, 12 months, 24 months
Secondary outcomes (4)
Type of impaction
According to Archer's classification it is possible to have seven types of impaction: mesio-angular, disto-angular, bucco-angular, linguo-angular, horizontal, vertical, inverted.
Measured: Baseline
Clinical Attachment Level (CAL)
Distance between the cemento-enamel junction and the apical location of the probe's tip
Measured: Baseline, 1 month, 6 months, 12 months, 24 months
Recession (REC)
Distance between the free gingival margine and the cemento-enamel junction (CEJ)
Measured: Baseline, 1 month, 6 months, 12 months, 24 months
Keratinized Tissue (KT)
Distance between the muco-gingival line and the free gingival margin
Measured: Baseline, 1 month, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start27 Mar 2024
- Primary completion27 Mar 2026 (estimated)
- Study completion15 Sep 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Senese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malpassi Chiara, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520137
- Sponsor's protocol ID
- 26617
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Upper Third Molars Extraction and Upper Second Molars Periodontal Disease: a Prospective Clinical Observational Study
- ClinicalTrials.gov ID
- NCT06520137
- Acronym / sponsor ID
- 26617
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria SeneseUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 27 Mar 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 25 Jul 2024 (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 aim of the study is to evaluate the changes in periodontal conditions on the distal aspect of the second maxillary molar after the extraction of the maxillary wisdom tooth. As secondary outcome patient- related and tooth-related factors will be analysed to evaluate their effects on the periodontal varibales during time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A with PPD ≤ 3 mm | – | Procedure: Tooth extraction |
| Group B with PPD ≥ 4 mm | – | Procedure: Tooth extraction |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- Hospital population.
Key inclusion criteria (3 listed)
- Age more than 18 years or older
- Presence of an impacted upper wisdom tooth that need to undergo surgical extraction
- Participants need to be able to sign and understand the informed consent and to follow the study-related procedures.
Key exclusion criteria (6 listed)
- People that have compromised general health conditions (ASA 3, 4, 5, 6)
- Patients that assumed antibiotics in the last 6 months
- Pregnant or breastfeeding women
- Patients who suffer from periodontitis stage III and IV
- Presence of a third molar with incomplete root formation is not taken into account for the surgical extraction.
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 |
|---|---|---|
| Tooth extractionExtraction of maxillary third molars | Procedure or surgery | Group A with PPD ≤ 3 mm, Group B with PPD ≥ 4 mm |
Primary outcome
Probing Pockeet Depth (PPD)
Time frame: Baseline, 1 month, 6 months, 12 months, 24 months
Distance between the free gingival margin and the apical location of the probe's tip.
Bone Level (BL)
Time frame: Baseline, 1 month, 6 months, 12 months, 24 months
Distance between the bone crest and the cemento-enamel junction (CEJ)
4 secondary outcomes
Type of impaction
Time frame: Baseline
Clinical Attachment Level (CAL)
Time frame: Baseline, 1 month, 6 months, 12 months, 24 months
Recession (REC)
Time frame: Baseline, 1 month, 6 months, 12 months, 24 months
Keratinized Tissue (KT)
Time frame: Baseline, 1 month, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Azienda Ospedaliera Universitaria Senese 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 3 inclusion and 6 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 25 Jul 2024. 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?
Contact Chiara Malpassi (+ 39 3331375702, chiara.malpassi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pockeet Depth (PPD) (time frame: Baseline, 1 month, 6 months, 12 months, 24 months). 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 25 Jul 2024.