Well-being after root canal treatment with RISA irrigation. Frequency and intensity of postoperative pain.
ID
Bron
Verkorte titel
Aandoening
Apical periodontitis, pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
pain / no pain
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Well-being after root canal treatment with RISA irrigation. Frequency and intensity of postoperative pain.
Onderzoeksopzet
intake, consultation, treatment, control after 1 year a total of 7 questionaires are filled out
Onderzoeksproduct en/of interventie
irrigation RISA
Publiek
S.V. van der Waal
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
s.vd.waal@acta.nl
Wetenschappelijk
S.V. van der Waal
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
s.vd.waal@acta.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6588 |
NTR-old | NTR6762 |
Ander register | : 2017.015 |
Samenvatting resultaten
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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