Acute Inflammation After Wisdom Tooth Removal

NCT03048175 | Completed

• 1 other identifier: 2198
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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 Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.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

Conditions

Tooth Impacted

Keywords

C-reactive protein; Systemic inflammation; Third molar; Wisdom tooth

Outcome Measures

Primary Outcomes (1)

• Changes in C-reactive protein (CRP)

  High-Sensitive plasmatic C-reactive protein

  baseline, 24 and three months after the second extraction

Secondary Outcomes (4)

• Changes in plasma malondialdehyde (MDA)

  baseline, 24 and three months after the second extraction

• Changes in lipoperoxides (LOOH)

  baseline, 24 and three months after the second extraction

• Changes in ferric-reducing antioxidant power (FRAP)

  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

  baseline, 24 and three months after the second extraction

Study Arms (2)

Cases: wisdom tooth pathology

EXPERIMENTAL

Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal

Procedure: Wisdom tooth removal

Controls: no wisdom tooth pathology

NO INTERVENTION

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

Interventions

Wisdom tooth removal 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.

Cases: wisdom tooth pathology

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• younger than 18 years and older than 65 years;
• pregnant or lactating females;
• females using contraceptive methods;
• suffering from any systemic illness;
• 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.

Sponsors & Collaborators

• University of Pisa: lead

Related Publications (1)

• 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.

  PMID: 28759304 DERIVED

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Code was assigned to each participant. No info on whether they belong to cases or control was given to researchers and statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Case-control intervention trial: cases are treated for pathology. Controls do not have pathology.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 9, 2017
• Study Start: April 19, 2007
• Primary Completion: June 15, 2009
• Study Completion: June 30, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share