ClinicalTrials.gg
CompletedNCT06174909Updated Dec 18, 2023

In Vivo Comparative Study of Calcium Hydroxide and Triple Antibiotic Paste in Intracanal Medicament in Emergency Pain Reduction

An interventional study of Calcium Hydroxide and Triple Antibiotic paste in Pain, sponsored by Pakistan Institute of Medical Sciences. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Pakistan Institute of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2022, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Interappointment pain is a universal concern for clinician and patients alike which remain a significant challenge for dentalprofessional.The purpose of this study was to evaluate the effects of calcium hydroxide, and triple antibiotic paste as intra-canal medicaments in emergency pain reduction in patients undergoing endodontic treatment .

Read the detailed description

Before commencing treatment, the complete procedure was explained to the patients and consent was obtained. Local anesthesia was administered, and the tooth was isolated under rubber dam. Access cavity preparation was done, and canals were explored using endodontic explorer (DG-16,). Working length was determined with No. 15 K-files using apex locater and was confirmed with radiovisiography . Cleaning and shaping were along with copious irrigation using 3% NaOCl and 0.9% saline . Canals will be dried and one of the following two medicaments will be inserted into the canals in random sequences

Group 1 :Calcium Hydroxide:

CH was placed as an intracanal medicament. Atotal of 100 mg of CH powder was dispensed and mixed with one drop of pro-pylene glycol on a clean and dry glass slab to prepare a thick paste-like consistency. This paste was carried into the canal , and access opening was restored temporarily with temporary cement

Group 2: Triple antibiotic paste:

It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. The crushed powder was passed through a fine sieve to remove heavy filler particles and obtain a fine powder. The ciprofloxacin, metronidazole, and clindamycin powders thus obtained were weighed separately and mixed in a 1:3 proportions respectively,to obtain triple antiobiotic mixture.A total 100 mg of this Ta mixture was dispensed and mixed with one drop of propylene glycol to get a thick paste-like consistency. This paste was placed gently compacted into the canal , and access opening was restored with temporary cement Before dismissal ,no antiobiotics will be prescribed and the patients who had been taking antibiotics will be recorded.Patient will be requested to stop antibiotics.They will be requested to stop analgesic.The preoperative pain experienced on the previous night will be recorded using visual analogue scale.Patient will be then instructed to record the degree of pain experienced after 2nd day ,7th day and 15 day postoperatively

02

Conditions studied

  • Pain

Browse trials for

03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 90 is above the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Pakistan Institute of Medical Sciences is the lead sponsor of 54 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Patients who agree to particapte in study 2. Patient with age between 18 to 60 years 3. single rooted teeth with closed apices included in the study 4. Patient diagnosed with Necrosed tooth with acute apical periodontitis will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • 1. Teeth with incomplete root formation. 2. Severe periodontal problem. 3. Vertical or horizontal root fractures were excluded from the study 4. Retreatment cases will not included in study. 5. Patients with systemic problems, for example, diabetes and autoimmune disease, and so on, will not be selected for this study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Calcium Hydroxide

    Calcium hydroxide has antimicrobial properties and tissue altering effect,used into root canals for the purpose of inhibiting coronal invasion of bacteria from the oral cavity".

    Drug: Calcium Hydroxide

  • Active comparator
    Triple antibiotic Paste

    Triple antibiotic paste is combination of ciprofloxcin,metronidazole,and minocycline,used into root canals for the purpose of inhibiting coronal invasion of bacteria from the oral cavity".

    Drug: Triple Antibiotic paste

Interventions

  • After completion of canal and shaping ,canal was dried and CH was placed as an intracanal medicament. A total of 100 mg of CH powder was dispensed and mixed with one drop of pro-pylene glycol on a clean and dry glass slab to prepare a thick paste-like consistency. This paste was carried into the canal and access opening was restored temporarily with temporary cement

  • DrugTriple Antibiotic paste

    Drug pages: Ciprofloxacin · Metronidazole · Minocycline

    After completion of cleaning and shaping ,canal was dried and tripe antibiotic was placed as intracanal medicament.It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. This paste was placed gently compacted into the canal and access opening was restored with temporary cement

06

What researchers measure

Primary outcomes

  1. Postoperative pain

    Pain after root canal treatment

    Time frame: Immediately after the procedure

07

Study locations

1 site
  • School of Dentistry
    Islamabad, 0920, Pakistan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2022 to primary completion in Aug 2023, 9 months.

Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 9 months is below that.

Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2023
First posted
Dec 18, 2023
StartActual
Nov 1, 2022
Primary completionActual
Aug 1, 2023
CompletionActual
Aug 10, 2023
Last update
Dec 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06174909
Lead sponsor
Pakistan Institute of Medical Sciences
Responsible party
Ahsen amin (Principal investigator, Pakistan Institute of Medical Sciences) — Principal investigator
First posted
Dec 18, 2023
Start date
Nov 1, 2022
Primary completion
Aug 1, 2023
Completion
Aug 10, 2023
Last update
Dec 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Calcium Hydroxide

Start the discussion