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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45736
Enrollment
30
Registered
2018-03-13
Start date
2018-02-14
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lokale ontstekingsreactie als gevolg van een lokale afgebakende infectie in een gebitselement apical periodontitis root tip inflammation

Interventions

Teeth are treated with a non-surgical root canal treatment (NSRCT with RISA irrigation. During a NSRCT RISA is going to be used instead of the currently employed 2%-sodium hypochlorite solution, to
endodontic
postoperative
root canal treatment

Sponsors

Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Frequency and intensity of postoperative pain. Quantity of pain medication taken before and after the root canal treatment.

Secondary

MeasureTime frame
Periapical lesion size before root canal treatment and one year after root canal treatment.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)