- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06520137
Third Molars Extraction and Periodontal Disease
July 24, 2024 updated by: Malpassi Chiara, Azienda Ospedaliera Universitaria Senese
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chiara Malpassi
- Phone Number: + 39 3331375702
- Email: chiara.malpassi@gmail.com
Study Contact Backup
- Name: Simone Grandini
- Phone Number: +39 3357045335
- Email: grandini@unisi.it
Study Locations
-
-
Italy/SI
-
Siena, Italy/SI, Italy, 53100
- Recruiting
- University of Siena
-
Contact:
- Simone Grandini
- Phone Number: + 39 3357045335
- Email: grandini@unisi.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Hospital population.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A with PPD ≤ 3 mm
|
Extraction of maxillary third molars
|
|
Group B with PPD ≥ 4 mm
|
Extraction of maxillary third molars
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 1 month, 6 months, 12 months, 24 months
|
|
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)
|
Baseline, 1 month, 6 months, 12 months, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of impaction
Time Frame: Baseline
|
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.
|
Baseline
|
|
Clinical Attachment Level (CAL)
Time Frame: Baseline, 1 month, 6 months, 12 months, 24 months
|
Distance between the cemento-enamel junction and the apical location of the probe's tip
|
Baseline, 1 month, 6 months, 12 months, 24 months
|
|
Recession (REC)
Time Frame: Baseline, 1 month, 6 months, 12 months, 24 months
|
Distance between the free gingival margine and the cemento-enamel junction (CEJ)
|
Baseline, 1 month, 6 months, 12 months, 24 months
|
|
Keratinized Tissue (KT)
Time Frame: Baseline, 1 month, 6 months, 12 months, 24 months
|
Distance between the muco-gingival line and the free gingival margin
|
Baseline, 1 month, 6 months, 12 months, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2024
Primary Completion (Estimated)
March 27, 2026
Study Completion (Estimated)
September 15, 2026
Study Registration Dates
First Submitted
July 20, 2024
First Submitted That Met QC Criteria
July 24, 2024
First Posted (Actual)
July 25, 2024
Study Record Updates
Last Update Posted (Actual)
July 25, 2024
Last Update Submitted That Met QC Criteria
July 24, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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