Effect of Double Antibiotic Paste Versus Calcium Hydroxide on RANKL/OPG Levels

NCT04593238 | Unknown

• 1 other identifier: ENDO: 3-3-6
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study is to evaluate the effect of double antibiotic paste when compared to Ca (OH)2, in terms of RANKL and OPG levels in chronic periapical lesions and correlate the results with periapical bone healing findings after a follow up period of one year.

Conditions

Biological Markers

Outcome Measures

Primary Outcomes (1)

• Percentage change of RANKL/OPG levels

  RANKL/OPG levels will be measured post-instrumentation and 1 week postoperatively, using Absorbance using ELISA test, to calculate the percentage change of RANKL/OPG levels

  measured Immediately post-instrumentation and after one week

Secondary Outcomes (1)

• Periapical healing

  CBCT scans will be done preoperatively and 6 and 12 months postoperatively

Study Arms (2)

Double antibiotic paste intra-canal medication group (n=25)

EXPERIMENTAL

500 mg Metronidazole tablet+ 500 mg Ciprofloxacin tablet crushed into powder and mixed together with salline to form a creamy mix to be placed inside the root canal for 1 week.

Drug: Double Antibiotic paste

Calcium hydroxide intra-canal medication group (n=25)

ACTIVE COMPARATOR

Calcium hydroxide paste (Metapaste) placed inside the root canal for 1 week

Drug: Calcium Hydroxide Paste - Non-Setting

Interventions

Double Antibiotic paste DRUG

Metronidazole and Ciprofloxacin

Also known as: Bimix

Double antibiotic paste intra-canal medication group (n=25)

Calcium Hydroxide Paste - Non-Setting DRUG

Calcium hydroxide paste to be delivered inside the canal as an intra-canal medication

Also known as: Metapaste

Calcium hydroxide intra-canal medication group (n=25)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are free from any physical or mental handicapping conditions and with no underlying systemic diseases.
• Age between 20-45years old.
• Males \& Females.
• Single canaled teeth:
• Diagnosed clinically with asymptomatic apical periodontitis.
• Absence of spontaneous pain
• Size of periapical radiolucency: 2-4 mm (i.e. score 3 according to CBCT periapical index proposed by Estrela)30, including only the tested tooth.
• Patients who didn't use any NSAIDs or antibiotics for 1 month before treatment.
• Patients' acceptance to participate in the trial.

You may not qualify if:

• \- Medically compromised patients.
• Pregnant women.
• Patients reporting bruxism or clenching.
• Patients allergic to ciprofloxacin or metronidazole.
• Teeth associated with acute periapical abscess and/or swelling.
• Greater than grade I mobility or pocket depth greater than 5mm.
• Size of periapical radiolucency is less than 2 mm or greater than 4 mm.
• Non restorable teeth.
• Immature teeth.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant lecturer

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10