No registrations found.
ID
Source
Brief title
Health condition
Apical periodontitis, pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
pain / no pain
Secondary outcome
healing apical periodontitis
Background summary
Rationale: After a series of laboratory tests, where RISA root-canal cleanser (RISA) showed good antimicrobial and biocompatible properties, the tolerance to the newly-devised compound is to be tested in the clinic in humans.
Primary objective: To assess the tolerance to RISA after its the application in the root-canal system during root canal treatment.
The secondary objective is to evaluate periapical radiolucency size on intra-oral radiographs of teeth treated with RISA.
Study objective
Well-being after root canal treatment with RISA irrigation. Frequency and intensity of postoperative pain.
Study design
intake, consultation, treatment, control after 1 year a total of 7 questionaires are filled out
Intervention
irrigation RISA
S.V. van der Waal
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
s.vd.waal@acta.nl
S.V. van der Waal
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
s.vd.waal@acta.nl
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 (see fig. 1) (Heft & Parker 1984)
- no or mild swelling and no draining sinus tract on affected tooth.
- 18 – 75 years.
- completed the medical history questionnaire.
- 1st or 2nd molar, 1st or 2nd premolar
- DPSI of subject tooth is ≤3-
- tooth mobility ≤1
- signed the informed consent form
Exclusion criteria
- pain >36 on Heft-Parker VAS scale (fig. 1)
- subject tooth with a mobility score 2 or more
- subject tooth with a 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 a periapical
- previous (non)surgical (root-canal) treatment on subject tooth
- draining sinus tract or exacerbation 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/II,
- chronic inflammatory diseases like morbus Crohn or rheumatoid arthritis
- known sensitization to sorbic acid and its salts
- pain >36 on Heft-Parker VAS scale (fig. 1)
- subject tooth with a mobility score 2 or more
- subject tooth with a 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 a periapical
- previous (non)surgical (root-canal) treatment on subject tooth
- draining sinus tract or exacerbation originating from affected tooth
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6588 |
| NTR-old | NTR6762 |
| Other | : 2017.015 |
Summary results
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2: van der Waal SV, Jiang LM, de Soet JJ, van der Sluis LW, Wesselink PR, Crielaard W. Sodium chloride and potassium sorbate: a synergistic combination against Enterococcus faecalis biofilms: an in vitro study. Eur J Oral Sci. 2012