Apical Periodontitis, Post Operative Pain, Acute
Conditions
Brief summary
When a tooth's nerve dies, inflammation can develop at the tip of the tooth's root. Root canal treatment is carried out to allow this inflammation to heal. Sometimes, inflammation persists in a tooth that has already undergone root canal treatment. In such cases, the root canals may be re-treated to allow the inflammation to heal. During root canal treatment, the root canals inside the tooth are cleaned and then filled. Various instruments are used to clear the root canal along its entire length, so that the entire canal can be disinfected using antiseptic products. To allow these products to work more effectively, they can be activated. This activation can be achieved, amongst other methods, using vibrations caused by a plastic tip vibrating at a sonic frequency within the liquid. Another method of activation involves the use of a laser, which delivers pulsed energy. This creates shock waves in the liquid. Previous research has shown that root canals can be cleaned more effectively through the use of activation techniques. This study aims to investigate whether the inflammation present at the root tip heals more effectively following the use of activation methods for the disinfectant. The use of the laser is compared with that of the sonic vibration instrument, and with a group in which the disinfectant is not activated. The effect of the activation method on post-treatment pain is also investigated.
Interventions
DEVICEsonically activated irrigation
The irrigant is activated after mechanical preparation with a plastic Eddy-tip (f = 6000 Hz) inserted up to 1 - 3 mm short of the working length. Three 20 s activation cycles are performed per canal, with 2 mL irrigation in each root canal between the cycles.
The irrigant is activated after mechanical preparation with a pulsed Er:YAG laser (Fotona Fidelis III, PIPS, E = 20 mJ, f = 20 Hz, t = 50 μs). These settings result in a power of 0.4 W. Due to the high absorption of the Er:YAG wavelength in the irrigant, mechanical effects occur (cavitation), rather than thermal effects. As a result, the risk of thermal damage is negligible. The tip of the laser is kept at the canal orifice, but not inserted into the root canal. During activation, irrigant is continuously added to the pulp chamber, so the root canals and pulp chamber are consistently immersed in irrigating solution. Three 20 s activating cycles per orifice are executed, with intermittent flushing of the root canal with 2 mL irrigant.
The root canals are irrigated with 3% NaOCl, using a 27G notched needle, adapted to a 3 mL syringe and inserted up to 2 - 3 mm short of working length. Two millilitres of irrigant are used between the different instruments.
Sponsors
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Mature permanent tooth * Pulpal diagnosis: pulp necrosis, previously initiated treatment, root filled * Apical diagnosis: asymptomatic apical periodontitis * Pre-operative pain of 0 on the Visual Analogue Scale (VAS)
Exclusion criteria
* Permanent teeth with immature roots or open apices * Teeth not eligible for orthograde (re)treatment * Teeth with acute pain * Teeth with periodontal pockets ≥ 5 mm * Teeth with persistent intracanal drainage * Non-restorable teeth * Pregnant women * Patients who took drugs with possible influence on the pain sensation within 12 hours before treatment * Patients with pain from one or multiple teeth * Patients with contra-indications for the use of NSAID * Patients with a known or suspected malignancy * Patients with a history of chemotherapy within five years * Patients with a history of radiation therapy in the head and neck region * Patients with a history of metabolic bone diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-operative pain | Post-operative pain is scored immediately after the treatment and 6 hours, 24 hours, 48 hours, 72 hours and 96 hours after treatment. | The post-operative pain immediately after completion of treatment is scored on the Visual Analogue Scale (VAS), with a score between 0 (no pain) and 10 (worst pain imaginable). Patients are asked to fill out a pain diary 6 hours, 24 hours, 48 hours, 72 hours and 96 hours after treatment with a pain score on the VAS. |
| tooth survival | up to 2 years post-treatment | presence of the treated tooth inside the mouth |
| apical healing | up to 2 years post-treatment | The pre-operative and recall periapical radiographs are compared for the periapical index (PAI). On the radiographs, the apical periodontitis lesion is outlined and the surface of the lesion is calculated using software. The surface of the apical periodontitis lesion on the follow-up radiograph is compared to the pre-operative radiograph. Teeth are categorized into the following three outcome categories based on analysing the change in the PAI: * Strict radiographic success (healed teeth): absence of clinical signs or symptoms, and PAI-score of 1 or 2 at follow-up. * Loose radiographic success (healing teeth): absence of clinical signs or symptoms, and a lower PAI-score (or smaller surface of the lesion) compared to the pre-operative radiograph. * Failure (non-healing): clinical signs or symptoms (including pain, swelling, sinus tract), or asymptomatic with an unchanged PAI-score (or surface of the lesion), or increase in PAI-score (or surface of the lesion) at follow-up. |
Countries
Belgium
Contacts
CONTACTMieke De Bruyne, Prof. dr.
Outcome results
None listed