Tooth ImpactedOTTO-SYSTNCT03048175
Acute Inflammation After Wisdom Tooth Removal
A study testing Wisdom tooth removal in people with Tooth Impacted, run by University of Pisa.
Trial summary
Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the level of general body inflammation of subjects with impacted or semi-impacted third molars. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tooth Impacted
- What is being tested?
- Wisdom tooth removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2007to 30 Jun 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cases: bilateral wisdom tooth pathology.
- control: agenesia/previous extraction/no symptoms of the lower third molars.
Who cannot join
- younger than 18 years and older than 65 years;
- pregnant or lactating females;
- females using contraceptive methods;
- suffering from any systemic illness;
- undergoing any pharmacological treatment within 30 days prior to the inclusion
- patients affected by periodontal disease (radiographic diagnosis of vertical bone defects or bone resorption equal to 20% of the root length);
- patients with periapical and periradicular radiolucent areas X-ray detectable;
- patients unable to participate to study.
About this study
Official title: Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study
Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the level of general body inflammation of subjects with impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of wisdom teeth on the overall health are not known.
Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without pathology associated to or history of previous extraction of both wisdom teeth.
Read more
In both groups a medical and dental examination will be performed at the baseline and 3 months after baseline for the control group or after the second third molar extraction in the control group. Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.
Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.
Read the detailed description
Third molar extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the systemic aspect of subjects with impacted or semi-impacted third molars and the possible effects of surgical removal on their systemic parameters. A case-control study of 40 subjects has been designed to evaluate i) the overall systemic inflammation and metabolism of subjects with bilateral third molars compared to subjects with no third molars and ii) the effect of bilateral removal in the immediate and medium postsurgical period. Systemic parameters are evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.
- Conditions
- Tooth Impacted
- Being tested
- Wisdom tooth removal
- Keywords
- C-reactive protein, Systemic inflammation, Third molar, Wisdom tooth
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wisdom tooth removalProcedure or surgery
After inferior dental and buccal nerve anesthesia a triangular full thickness flap with releasing incision on the mesio-buccal aspect of the second molar is designed. Ostectomy is then performed and tooth is sectioned and gently elevated. Once all the tooth components are extracted, the socket is carefully inspected and flap is sutured with interrupted sutures.
| Study group | Role | What they receive |
|---|---|---|
| Cases: wisdom tooth pathology | Experimental | Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal Receives: Procedure: Wisdom tooth removal |
| Controls: no wisdom tooth pathology | No intervention | Subjects showing agenesia/previous extraction/no symptoms of the lower third molars. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in C-reactive protein (CRP)
High-Sensitive plasmatic C-reactive protein
Measured: baseline, 24 and three months after the second extraction
Secondary outcomes (4)
Changes in plasma malondialdehyde (MDA)
plasma malondialdehyde
Measured: baseline, 24 and three months after the second extraction
Changes in lipoperoxides (LOOH)
lipoperoxides levels in plasma
Measured: baseline, 24 and three months after the second extraction
Changes in ferric-reducing antioxidant power (FRAP)
FRAP levels in plasma
Measured: baseline, 24 and three months after the second extraction
Changes in endothelial flow-mediated dilation (FMD) calculated as maximal percentual increase in diameter of the blood vessel above baseline
Endothelium-dependent response of the brachial artery in response to increased blood flow by high resolution ultrasound with a 7.5 MHz linear array transducer
Measured: baseline, 24 and three months after the second extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start19 Apr 2007
- Primary completion15 Jun 2009
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth ImpactedStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case-control intervention trial: cases are treated for pathology. Controls do not have pathology.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048175
- Sponsor's protocol ID
- 2198
- Acronym
- OTTO-SYST
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Graziani F, D'Aiuto F, Gennai S, Petrini M, Nisi M, Cirigliano N, Landini L, Bruno RM, Taddei S, Ghiadoni L. Systemic Inflammation after Third Molar Removal: A Case-Control Study. J Dent Res. 2017 Dec;96(13):1505-1512. doi: 10.1177/0022034517722775. Epub 2017 Jul 31.
PubMed 28759304
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study
- ClinicalTrials.gov ID
- NCT03048175
- Acronym / sponsor ID
- OTTO-SYST / 2198
- Conditions
- Tooth Impacted
- Keywords
- C-reactive protein, Systemic inflammation, Third molar, Wisdom tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 19 Apr 2007 (actual)
- Primary completion
- 15 Jun 2009 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the level of general body inflammation of subjects with impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of wisdom teeth on the overall health are not known.
Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without pathology associated to or history of previous extraction of both wisdom teeth.
In both groups a medical and dental examination will be performed at the baseline and 3 months after baseline for the control group or after the second third molar extraction in the control group. Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.
Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.
Detailed description
Third molar extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the systemic aspect of subjects with impacted or semi-impacted third molars and the possible effects of surgical removal on their systemic parameters. A case-control study of 40 subjects has been designed to evaluate i) the overall systemic inflammation and metabolism of subjects with bilateral third molars compared to subjects with no third molars and ii) the effect of bilateral removal in the immediate and medium postsurgical period. Systemic parameters are evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Case-control intervention trial: cases are treated for pathology. Controls do not have pathology.
| Arm | Type | Receives |
|---|---|---|
| Cases: wisdom tooth pathology | Experimental | Procedure: Wisdom tooth removalSubjects affected by bilateral wisdom tooth pathology, undergoing surgical removal |
| Controls: no wisdom tooth pathology | No intervention | –Subjects showing agenesia/previous extraction/no symptoms of the lower third molars. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cases: bilateral wisdom tooth pathology.
- control: agenesia/previous extraction/no symptoms of the lower third molars.
Key exclusion criteria (8 listed)
- younger than 18 years and older than 65 years;
- pregnant or lactating females;
- females using contraceptive methods;
- suffering from any systemic illness;
- undergoing any pharmacological treatment within 30 days prior to the inclusion
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 |
|---|---|---|
| Wisdom tooth removalAfter inferior dental and buccal nerve anesthesia a triangular full thickness flap with releasing incision on the mesio-buccal aspect of the second molar is designed. Ostectomy is then performed and tooth is sectioned and gently elevated. Once all the tooth components are extracted, the socket is carefully inspected and flap is sutured with interrupted sutures. | Procedure or surgery | Cases: wisdom tooth pathology |
Primary outcome
Changes in C-reactive protein (CRP)
Time frame: baseline, 24 and three months after the second extraction
High-Sensitive plasmatic C-reactive protein
4 secondary outcomes
Changes in plasma malondialdehyde (MDA)
Time frame: baseline, 24 and three months after the second extraction
Changes in lipoperoxides (LOOH)
Time frame: baseline, 24 and three months after the second extraction
Changes in ferric-reducing antioxidant power (FRAP)
Time frame: baseline, 24 and three months after the second extraction
Changes in endothelial flow-mediated dilation (FMD) calculated as maximal percentual increase in diameter of the blood vessel above baseline
Time frame: baseline, 24 and three months after the second extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 28759304Graziani F, D'Aiuto F, Gennai S, Petrini M, Nisi M, Cirigliano N, Landini L, Bruno RM, Taddei S, Ghiadoni L. Systemic Inflammation after Third Molar Removal: A Case-Control Study. J Dent Res. 2017 Dec;96(13):1505-1512. doi: 10.1177/0022034517722775. Epub 2017 Jul 31.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Wisdom tooth removal in people with Tooth Impacted, run by University of Pisa.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in C-reactive protein (CRP) (time frame: baseline, 24 and three months after the second extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048175, which also lists 1 linked publication.
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 9 Feb 2017.