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临床试验/CTRI/2024/11/076836
CTRI/2024/11/076836尚未招募4 期

Comparative evaluation of the effect of 970 nm diode laser with or without N acetyl cysteine on post operative pain after endodontic treatment in teeth with symptomatic apical periodontitis: a randomized clinical trial

Joe Paul Umbavu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月29日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
post operative pain assessment after root canal treatment

研究概览

简要总结

METHODOLOGYMandibular
block anesthesia performed using local anesthetics solution 1.8ml 2%
lidocaine with 1:80000 epinephrine. The procedure started after lip numbness was
achieved. Occlusal reduction will be done followed by  straight-line access cavity  and the procedure was completed under rubber
dam isolation. The working length was determined using an electronic apex
locator (J morita), and Endomotor (Canalpro cl2i ,Coltene ,India) , Protaper
gold  (Dentsply Maillefer, Ballaigues,
Switzerland) was  used according to the
manufacturer’s instructions for cleaning and shaping .

A size 10 K-file was used to maintain apical patency, 2 mL 2.5% sodium hypochlorite was used between in-and-out pecking motions, and After instrumentation, The needle was advanced to a depth of 2–3 mm short of WL and the canal will be irrigated with 3 mL of  2.5% NaOCl. Final irrigation will be done with 5 mL of 17% EDTA for 1 min followed by a final rinse with 5ml of saline.

Randomization

After that, patients were randomly assigned to one of the three groups based on the post operative therapy

 ROOT CANAL INSTRUMENTATION

The  patients will be randomly divided into 3 groups containing  teeth in  each group namely:

§  GROUP I(n=20):  N acetyl cysteine

§  GROUP II(n=20) : 970 nm diode laser

§  Group II(n=20): 970 nm diode laser+ N acetyl cysteine

 Group I :

After the canals are dried with paper point N acetyl cysteine  paste was applied as intra-canal medicament , and the access cavity was sealed using a temporary restorative material

GROUP II:

The final irrigation was performed , after the canals were dried with paper-points. During the laser treatment, both the operator and patient wore protective eyewear. Laser irradiation was applied using a 970-nm diode laser (Sirolaser blue , Dentsply Maillefer, Ballaigues, Switzerland) coupled with a 200-μm optical fibre. The settings were as follows: output power of 1.5 W in the pulsed mode irradiation for 10 s, followed by a 10-s pause, which comprised one cycle. This cycle was applied four times to each root canal. The  power used was 1.5 W  with a low frequency of 15 Hz. The optical fibre tip (length of 25 mm) was inserted at the working length. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to coronal using a continuous circling movement touching the dentinal walls in one cycle for each power. and the access cavity was sealed using a temporary restorative material.

GROUP III:

The final irrigation was performed as in the control group, and the canals were dried with paper points. During the laser treatment, both the operator and patient wore protective eyewear. Laser irradiation was applied using a 970-nm diode laser (sirolaser blue Dentsply Maillefer, Ballaigues, Switzerland ) coupled with a 200-μm optical fibre .The settings were as follows: power of 1.5 W and in the pulsed mode , irradiation for 10 s, followed by a 10-s pause, which comprised one cycle. This cycle was applied four times to each root canal. The power used was 1.5 W with a low frequency of 15 Hz. The optical fibre tip (length of 25 mm) was inserted at the working length. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to coronal using a continuous circling movement touching the dentinal walls in one cycle for each power.

Following the irradiation procedure, N acetyl cysteine  paste was applied as intra-canal medicament , and the access cavity was sealed using a temporary restorative material, as in the control group

Subsequently, a temporary restorative material (Cavit-G; 3 M ESPE, St Paul, MN) was used to seal the access cavity. At the time of the first visit, all the patients were given a VAS  to rate their PP. A second appointment was scheduled for 7 d later. All patients who met the final inclusion criteria were given  a pain chart to be completed to record the incidence of pain (yes/no), level of posttreatment pain and duration of pain (days). They were asked to submit the forms after 1 week. Patients have been prescribed an optional medication of ibuprofen (400 mg, 8–12 h). Patients were asked to record the information if they took the medication. A modified visual analogue scale (VAS) was employed for assessment and statistical comparison of pain scores: score 0, absolutely nothing; scores 1–3 (mild), very weak discomfort or mild pain but requiring no intervention and not influencing ordinary activities of daily life; does not require analgesics; scores 4–6 (moderate), moderate pain which is distracting for the patient and occasionally negatively influences the patient from performing his normal daily activities; the pain is relieved with analgesics; scores 7–10 (severe), this score range covered very severe and extremely severe/ unbearable pain that forces the patient to give up his/her daily activities and needs rest; this pain is not relieved by analgesics. (11) The patients were instructed to use 400 mg ibuprofen (Brufen; Abbott, Latina, Italy) if the pain was unbearable and asked to record analgesic intake. The patients recorded their pain experience on a customized form, which was also used to record any analgesic intake.

The following variables were recorded:

  1. Age

  2. Sex

  3. Tooth number

  4. Number of canals

  5. Preoperative pain on the VAS

  6. Preoperative and postoperative percussion pain levels (on the 7th day) on the VAS

  7. Pain level on the 8 hr ,24 hr, 48hr , 72hr & 7 day

  8. Analgesic intake after the procedure

At the second appointment, the ICM was removed from the root canals with final irrigation and using an F3/F2 file. The root canals were then obturated using the cold lateral condensation method with gutta-percha cones and AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland). The coronal restoration was finished using a resin composite (Filtek Z250, 3 M ESPE, St. Paul, MN

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Patients with mandibular molar with symptomatic apical periodontitis
  • •Periapical index up to 3 or
  • •Patient older than 18 to 60 years
  • •Spontaneous pain <3mm
  • •Percussion pain <3mm.

排除标准

  • •• Periodontal probing greater than 3mm • Previous root canal treatment • Swelling / sinus tract • Sever periodontal disease • Antibiotic use within last 5 days • Systemic disorders • Pregnancy and lactation • Traumatic occlusion • Severe crown destruction preventing rubber dam isolation • Presence of other teeth requiring RCT.

结局指标

主要结局

post operative pain assessment after root canal treatment

时间窗: pre operative pain assessment | post operative pain assessment at 8 hr after root canal treatment | post operative pain assessment at24 hr after root canal treatment | post operative pain assessment at48 hr after root canal treatment | post operative pain assessment at72 hr after root canal treatment | post operative pain assessment at 7DAY after root canal treatment

次要结局

  • post operative pain comparison among individuals of different age & gender(preoperative pain , post operative pain 8hr , post operative pain 24hr , post operative pain 48 hr , post operative pain 72 hr)

研究者

发起方
Joe Paul Umbavu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

JOE PAUL UMMBAVU

Bapuji Dental College and hospital

研究点 (1)

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