Acute Inflammation After Wisdom Tooth Removal

NCT ID: NCT03048175

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-19

Study Completion Date

2016-06-30

Brief Summary

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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 Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.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

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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

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Tooth Impacted

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Case-control intervention trial: cases are treated for pathology. Controls do not have pathology.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Code was assigned to each participant. No info on whether they belong to cases or control was given to researchers and statistician.

Study Groups

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Cases: wisdom tooth pathology

Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal

Group Type EXPERIMENTAL

Wisdom tooth removal

Intervention Type PROCEDURE

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.

Controls: no wisdom tooth pathology

Subjects showing agenesia/previous extraction/no symptoms of the lower third molars.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wisdom tooth removal

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* cases: bilateral wisdom tooth pathology.
* control: agenesia/previous extraction/no symptoms of the lower third molars.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Filippo Graziani, DDS MClinDent PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 28759304 (View on PubMed)

Other Identifiers

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2198

Identifier Type: -

Identifier Source: org_study_id

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