Effect of Irrigation With Antibiotic-containing Solutions on Postoperative Pain and Intra-canal Bacteria

NCT04035070 | Unknown Phase 4 FDA Drug

• 1 other identifier: CEBC-CU-2019-10-145
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

• The aim of this study is to compare the degree of postoperative pain and the antimicrobial effect in terms of bacterial count reduction after using co-amoxiclav-clindamycin solution versus MTAD and sodium hypochlorite irrigating solutions in patients with necrotic pulp.

Conditions

Necrotic Pulp

Keywords

antibiotic-containg solution; co-amoxiclav-clindamycin solution; MTAD; sodium hypochlorite; postoperative pain; antimicrobial efficacy; root canal irrigation

Outcome Measures

Primary Outcomes (1)

• postoperative pain: numerical rating scale

  intensity of pain by numerical rating scale from 0 to 10

  up to 48 hours after the first visit

Secondary Outcomes (1)

• intra-canal bacterial count

  72 hours after root canal preparation

Study Arms (3)

Root canal irrigation with co-amoxiclav-clindamycin solution

EXPERIMENTAL

Alternate irrigation with 1 mL antibiotic-containing solution followed by 4 mL 2.5% sodium hypochlorite solution between each size instrument and the consequent one. The antibiotic-containing solution will be prepared by mixing equal quantities of 1.2 gm Co-amoxiclav solution and 600 mg Clindamycin solution at a ratio of 1:1 by volume.

Combination Product: co-amoxiclav-clindamycin solution

Root canal irrigation with MTAD

EXPERIMENTAL

Irrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one.

Combination Product: MTAD

Root canal irrigation with 2.5% sodium hypochlorite

ACTIVE COMPARATOR

Irrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one.

Combination Product: 2.5% sodium hypochlorite

Interventions

co-amoxiclav-clindamycin solution COMBINATION_PRODUCT

antibiotic-containing solution will be prepared by mixing equal quantities of 1.2gm Co-amoxiclav solution and 600mg Clindamycin solution at a ratio of 1:1 by volume to be used as a root canal irrigating solution

Root canal irrigation with co-amoxiclav-clindamycin solution

MTAD COMBINATION_PRODUCT

mixture of 3% doxycycline hyclate, 4.25% citric acid and detergent (Tween 80) to be used as a root canal irrigating solution

Also known as: BioPure MTAD

Root canal irrigation with MTAD

2.5% sodium hypochlorite COMBINATION_PRODUCT

It will be prepared by adding 10mL of sterile distilled water to 10mL of 5.25% sodium hypochlorite solution to be used as a root canal irrigating solution

Root canal irrigation with 2.5% sodium hypochlorite

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Maxillary/mandibular single-rooted permanent teeth:
• Diagnosed clinically with pulp necrosis.
• Absence of spontaneous pain.
• Normal/slight widening in the periodontal membrane space (PMS).
• Patients' acceptance to participate in the trial.
• Patients who can understand numerical rating scale (NRS) and can sign the informed consent.

You may not qualify if:

• Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients show higher incidence of pain and lower healing rate.
• Patients with known allergy to penicillin or penicillin derivatives.
• Pregnant females: Avoid radiation exposure, anesthesia, and medication.
• If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively: Might alter their pain perception.
• Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
• Teeth that show association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
• Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
• Non-restorable teeth.
• Immature teeth.
• Radiographic evidence of periapical radiolucency, external or internal root resorption, vertical root fracture, perforation or calcification.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Endodontic Department - Faculty of Dentistry - Cairo University

Cairo, Egypt

Location

Related Publications (27)

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MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Interventions

MTAD (intracanal irrigant); Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Michel K Elias, M.Sc.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Maged M Negm, Ph.D.

  Cairo University

  STUDY DIRECTOR

• Heba El-Asfouri, Ph.D.

  Cairo University

  STUDY CHAIR

Central Study Contacts

Michel K Elias, M.Sc.

CONTACT

+2 0122 553 5090; michel.karam.5@gmail.com

Heba El-Asfouri, Ph.D.

CONTACT

+2 0100 527 6232; heba.elasfouri@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at endodontic department - School of dentistry - New Giza University

Study Record Dates

• First Submitted: July 21, 2019
• First Posted: July 29, 2019
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)