To assess the tolerance of RISA after its application in the root canal system during root canal treatment.
ID
Source
Brief title
Condition
- Other condition
- Ancillary infectious topics
Synonym
Health condition
lokale ontstekingsreactie als gevolg van een lokale afgebakende infectie in een gebitselement
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency and intensity of postoperative pain. Quantity of pain medication
taken before and after the root canal treatment.
Secondary outcome
Periapical lesion size before root canal treatment and one year after root
canal treatment.
Background summary
The prevalence of root tip inflammation after root canal treatment is very high
(45%). A very important reason is that the root canal infection can (partly)
persist after root canal treatment. Current root-canal irrigation fluids are
surface disinfectants and they are not able reach the complexity of root canal
systems. Moreover, currently most used root canal irrigation fluid is a sodium
hypochlorite solution which is a highly corrosive solution. After a series of
laboratory tests, where RISA root-canal cleanser (RISA) showed good cleaning
and biocompatible properties, the tolerance of the newly-devised compound is to
be tested in the clinic in humans.
Study objective
To assess the tolerance of RISA after its application in the root canal system
during root canal treatment.
Study design
Prospective case-series
Intervention
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 lubricate the root canal
instruments and the rinse the debris from the root canals.
Study burden and risks
The burden associated with participation consists of filling out one
questionnaire pre-operatively and seven questionnaires postoperatively. The
questionnaires contain a maximum of four questions. The risk associated with
participation is negligibly small. There will be no direct benefit for the
subjects as the applicability of RISA is to be established in this clinical
case series.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
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
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 |
|---|---|
| CCMO | NL59783.029.17 |