The tolerance to RISA root canal irrigation fluid determined in an in-vivo study

Completed

• Conditions: lokale ontstekingsreactie als gevolg van een lokale afgebakende infectie in een gebitselement; apical periodontitis; root tip inflammation; 10002252

• Registration Number: NL-OMON45736
• Lead Sponsor: Academisch Centrum Tandheelkunde Amsterdam (ACTA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-29
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- apical periodontitis has been diagnosed and confirmed with an intra-oral radiograph and appears on the radiograph as a radiolucent area around one or more root tips of the affected tooth. A root canal treatment has a reasonable/good prognosis (Sjögren et al. 1990) and the subject prefers NSRCT over tooth extraction or monitoring. The affected tooth has not previously received a complete root canal treatment.
- no spontaneous pre-operative pain or spontaneous pre-operative pain less than 36
- no or mild swelling
- if present, draining or no-draining sinus tract
- 18 - 75 years.
- completed the medical history questionnaire.
- all teeth except third molars
- DPSI of subject tooth is <=3-
- tooth mobility <=1
- signed the informed consent form

Exclusion Criteria

Subject tooth related criteria:
- third molar
- pain >36 on Heft-Parker VAS scale (fig. 1)
- subject tooth with a mobility score 2 or more
- subject tooth with a periodontal pocket depth DPSI >=3+
- subject tooth with open or incompletely formed root apices
- subject tooth that requires a post
- subject tooth with a vertical fracture or horizontal fracture extending below the cemento-enamel junction of the tooth
- teeth in the same quadrant requiring root canal therapy
- teeth with hypersensitive dentine in the same left or right facial half
- absence of periapical radiolucency in the presence of tenderness to percussion.
- absence of periapical radiolucency in the absence of pulp sensitivity
- previous completed (non)surgical (root-canal) treatment on subject tooth
- severe swelling originating from affected tooth;Current medication related criteria:
- chronic use of pain relief medication
- (par)enteral use of bisphosphonates
- systemic corticoid therapy;General-health related criteria:
- non-odontogenic facial pain
- any known infectious diseases (eg, human immunodeficiency virus, hepatitis B, hepatitis C, tuberculosis, or prion induced disease)
- history of cancer in the oral-maxillofacial region
- history of cancer in the last two years
- history of head and/or neck radiation therapy
- diabetes mellitus type I,
- chronic inflammatory diseases like morbus Crohn or rheumatoid arthritis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Frequency and intensity of postoperative pain. Quantity of pain medication<br /><br>taken before and after the root canal treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Periapical lesion size before root canal treatment and one year after root<br /><br>canal treatment.</p><br>