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Evaluation of Post Endodontic PainPhase 4NCT05985759

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 Periodontiti

A Phase 4 study testing N acetyle cystiene in people with Evaluation of Post Endodontic Pain, run by Bapuji Dental College & Hospital Davengere Karnataka at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

One of the most important aspect of endodontic treatment is management of postoperative pain management . Post operative pain after endodontic treatment is a frequent complication. frequency of post operative pain is between 3% to 58% . Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Evaluation of Post Endodontic Pain
What is being tested?
N acetyle cystiene
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndia
Study dates
1 Aug 2023to 30 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

None listed.

Who cannot join

  • • Periodontal probing greater than 3mm
  • Previous root canal treatment
  • Swelling / sinus tract
  • Sever periodontal disease
  • Antibiotic use within last 5 days
  • Systemic disorders
Show all 10Show fewer
  • Pregnancy and lactation
  • Traumatic occlusion
  • Severe crown destruction preventing rubber dam isolation
  • Presence of other teeth requiring RCT

Trial locations and contacts

1 site in 1 country.

Rashmi N C, MDS contact

7347228077

ncrashmi@yahoo.in

India1 site
  • Bapuji Dental College and Hospital , Davangere

    Davangere, Karnataka, 577004

    principal, bapuji dental college, MDS, 91-220579, 220580, bapujidental@gmail.com

    JOE PAUL UMBAVU, BDS

Other trials in India

About this study

Official title: 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

One of the most important aspect of endodontic treatment is management of postoperative pain management . Post operative pain after endodontic treatment is a frequent complication. frequency of post operative pain is between 3% to 58% .

Post operative pain could also occur as a result of inadequate instrumentation, extrusion of irrigation solutions, extrusion of intra-canal dressing, traumatic occlusion, missed canals, preoperative pain, periapical pathosis and extrusion of apical debris. Furthermore, instrument choice might also play an important role. The apical extrusion of infected debris during chemo-mechanical instrumentation of root canals might exacerbate the inflammatory response and cause peri-radicular inflammation.

Read more

The use of diode lasers, in addition to conventional endodontic therapy, has recently been proposed in RCT Various researchers have observed effective disinfection of the root canal by diode laser irradiation Due to the large water transmission capacities of diode lasers (810, 940 and 980-nm wavelengths), they can reach bacteria in deeper layers of dentinal tubules(3) Schoop et al. reported that using a 980-nm diode laser resulted in changes in dentinal surfaces and an increased bactericidal effect.

Other studies noted that laser irradiation decreases PP after RCT Over the years, studies have focused on identifying molecular mediators of inflammation induction, such as cytokines and chemokines in apical periodontitis. It was widely accepted that the loss of pro-inflammatory mediators was the 'turn off' signal of inflammation, ending subsequent responses passively.

Karapinar et al N-acetylcysteine (NAC) has been proposed as a potential alternative therapeutic agent in root canal treatment. NAC is an antioxidant mucolytic agent derivative of the amino acid L cysteine. As the precursor of glutathione, NAC can incorporate into cells and neutralize oxygen-derived free radicals (ROS), diminishing the cumulative effects of oxidative stress Previous studies have demonstrated the antimicrobial properties of NAC against several biofilm phenotypes, including oral pathogens such as Enterococcus faecalis, which is often found in endodontic infections. Moreover, NAC has been reported to exert anti-inflammatory activity by inhibiting the expression of lipopolysaccharide-induced inflammatory mediators.

Another study showed that the antibacterial effect of NAC is higher than that of NaOCl and CHX. More specifically, 200 mg/ ml solution of NAC was found to be more efficient than 5.25% NaOCl and 2% CHX in killing E. faecalis and S. mutant bacteria.(5) NAC exerts anti-inflammatory activity through its ability to inhibit the expression and release of a variety of proinflammatory cytokines. NAC can be a substitute for ibuprofen for post-endodontic pain. All these findings provide support for a superior potential for NAC in endodontic treatment.(6) Due to the scarcity of information on the effect of NAC as an intracanal medication, and the lack of systematic review on the same, this study aimed to compare and evaluate the post-operative pain when 970nm diode laser used with or without N acetyl cysteine as intracanal medicament

RESEARCH QUESTION : Will there be a difference in the postoperative pain after Endodontic treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser with or without N acetyl cysteine ?

RESEARCH HYPOTHESIS (H1): There will be a difference in the postoperative pain after Endodontic treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser with or without N acetyl cysteine

NULL HYPOTHESIS (H0): There will be no difference in the postoperative pain after Endodontic treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser with or without N acetyl cysteine

Read the detailed description
  1. To assess the postoperative pain after Endodontic treatment of mandibular molars with symptomatic apical periodontitis using N acetyl cysteine as intracanal medicament
  2. To assess the postoperative pain after Endodontic treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser .
  3. To assess the postoperative pain after Endodontic treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser with N acetyl cysteine .
  4. To compare the incidence of postoperative pain after endodontic treatment of mandibular molar with symptomatic apical periodontitis using N acetyl cysteine , 970nm diode laser , 970nm diode laser and N acetyl cysteine as intracanal medicament
  5. MATERIALS AND METHODS: 7.1 TYPE OF STUDY: An in vivo study 7.2 SOURCE: The study will be performed on mandibular molar. Study is to be conducted in Dept. of Conservative Dentistry and Endodontics, BDCH, Davangere

7.3 Materials and Equipment

  • 4 round bur ( Mani ,Japan ) Endo Z bur (Dentsply Sirona , India)
  • 10, #15 K files of 21mm length (MANI) Protaper gold (DENTSPLY SIRONA) of 21mm length Disposable syringes (BD Glide) Side vented needle (neoendo) Beakers 0.9% Normal saline (INFUTEC NS) Airotor handpiece (Rotomax) Canalpro cl2i endomotor (Coltene ,India) Apex locater (j morita root zx) 17% EDTA solution (DENTAL AVENUE) 2.5% NaOCl solution (SDFCL) N acetyl cysteine (Sigma Aldrich , Merck KGaA, Darmstadt, Germany) Sirolaser blue (Sirolaser blue , Dentsply Maillefer, Ballaigues, Switzerland) Cavit (Cavit-G; 3 M ESPE, St Paul, MN) EQUIPMENT
  • X ray PSP scanner (PSP -SOREDEX DIGORA Optime) 7.2 Method of collection of data (including sampling procedure, if any): Simple random

METHODOLOGY Mandibular 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).

The following variables were recorded:

  1. Age
  2. Sex
  3. Tooth number
  4. Number of canals
  5. Preoperative pain on the VAS 7. Preoperative and postoperative percussion pain levels (on the 7th day) on the VAS 8. Pain level on the 8 hr ,24 hr, 48hr , 72hr \& 7 day 11. 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).

Being tested
N acetyle cystiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N acetyle cystieneDrug

    N acetyle cystien is administerd due to its antibacterial action and anti inflamatory action

Study groups in NCT05985759
Study groupRoleWhat they receive
970nm diode laserNo interventionNot described
N acetyle cystieneExperimentalNot described
Receives: Drug: N acetyle cystiene
calcium hydroxideNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. modified visual analog scale

    evaluation of post endodontic pain

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05985759
Sponsor's protocol ID
ECR1652InstKA2022/230506010
Status last verified
Aug 2023
First submitted
21 Jul 2023
Last updated
14 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing N acetyle cystiene in people with Evaluation of Post Endodontic Pain, run by Bapuji Dental College & Hospital Davengere Karnataka at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rashmi N C, MDS (7347228077, ncrashmi@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified visual analog scale (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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