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

Primary Purpose

Necrotic Pulp

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
co-amoxiclav-clindamycin solution
MTAD
2.5% sodium hypochlorite
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp focused on measuring antibiotic-containg solution, co-amoxiclav-clindamycin solution, MTAD, sodium hypochlorite, postoperative pain, antimicrobial efficacy, root canal irrigation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Endodontic Department - Faculty of Dentistry - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Root canal irrigation with co-amoxiclav-clindamycin solution

Root canal irrigation with MTAD

Root canal irrigation with 2.5% sodium hypochlorite

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

postoperative pain: numerical rating scale
intensity of pain by numerical rating scale from 0 to 10

Secondary Outcome Measures

intra-canal bacterial count
pre and post-instrumentation samples to count intra-canal bacteria (CFU/mL)

Full Information

First Posted
July 21, 2019
Last Updated
October 13, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04035070
Brief Title
Effect of Irrigation With Antibiotic-containing Solutions on Postoperative Pain and Intra-canal Bacteria
Official Title
Effect of Irrigation With Antibiotic-containing Solutions Versus Sodium Hypochlorite on Postoperative Pain and Intra-canal Bacteria in Teeth With Necrotic Pulps (a Randomized Double-blind Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study. The operator will complete treatment of all cases in two visits as follows: Anesthesia will be achieved using inferior alveolar nerve block for mandibular premolar teeth and infiltration technique for maxillary anterior teeth with local anesthesic solution of 1.8 mL of 2% Mepivacaine HCl with 1:100,000 epinephrine. Caries and/or coronal restorations will be completely removed with sterile bur and rubber dam will then be applied. The operative field, including the tooth, the clamp and rubber dam sheet will be cleaned with 30% hydrogen peroxide for 30 seconds, followed by a sterile cotton swab with 5.25% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate. Access cavity will be prepared using a sterile round carbide bur size 3 and a sterile Endo-Z bur. The operative field and the pulp chamber will be cleaned and disinfected once again in the same way mentioned above. Patency of the root canals will be achieved using #10 or #15 size stainless steel hand K-files. Working length (WL) will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex. Debridement and mechanical preparation will be performed with the initial file along with 2 mL of 0.9% sterile saline solution and then a pre-instrumentation sample will be collected from the root canal. The pre-instrumentation sample (S1) will be collected as follows: a sterile paper point will be placed inside the root canal to soak up the fluid in the canal to a level approximately 1 mm short of the tooth apex. The paper point will be left in the canal for 60 seconds. This will be repeated using three sterile paper points. Paper points will then be transferred aseptically to tubes containing 20 mL of sterile thioglycolate broth. Microbiological analysis To test for the presence of cultivable bacteria, cultures will be inoculated in thioglycolate broth. For the identification of main anaerobic taxa, the root canal samples will be plated on 5% sheep blood agar, neomycin blood agar and phenyl ethyl alcohol agar with metronidazole (5μg, Oxoid, Basingstoke, UK) disc. Cultures will be incubated at 37°C for 72 hours in an anaerobic chamber . In addition, specimens will also be cultured aerobically on 5% sheep blood agar and MacConkey's agar. Mechanical preparation will be completed in a crown down technique with Protaper Next rotary files set on an endodontic motor adjusted at a speed of 300 rpm and torque of 2 Ncm. In-and-out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle, and apical thirds until attaining the established WL. All root canals will be enlarged to size X4 (40.06). The canal will be irrigated and recapitulated after the use of each instrument according to the allocated group as follows: Group 1: 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. Group 2: Irrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one. Group 3 (control): Irrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one. The root canal will be thoroughly irrigated with the allocated irrigant using a plastic disposable syringe with a gauge 30 side-vented needle reaching 1 mm short of the WL. The canal will then be dried using sterile paper points. Canals irrigated with NaOCl (groups 1 and 3) will be flushed with 5 mL of 5% sodium thiosulfate to inactivate the NaOCl followed by 5 mL 0.9% sterile saline solution. Canals irrigated with MTAD (group 2) will be flushed with 5 mL 0.9% sterile saline solution. A post-instrumentation sample (S2) will be taken as previously described and then the cavity will be sealed with a sterile cotton pellet and a temporary filling material . The patient will be instructed to record their pain level on NRS at 24 and 48 hours postoperatively and will be recalled after 72 hours. The patient will be prescribed Ibuprofen (400 mg) to be taken in case of intolerable pain. In the recall appointment, the root canal will be accessed under sterile conditions and will be flushed with 1mL sterile saline solution before a third sample (S3) is taken as previously described. Master cone fit radiograph will be taken and then the root canal will be dried using sterile paper points and filled with gutta percha points and resin-based sealer using cold lateral condensation technique. Access cavity will be sealed with a temporary filling material and the final restoration will be placed within one week. The patient will be asked to report any swelling, in such case, he/she will be appointed for clinical examination to assess the severity by a blinded assessor and to determine if systemic antibiotics/drainage will be needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp
Keywords
antibiotic-containg solution, co-amoxiclav-clindamycin solution, MTAD, sodium hypochlorite, postoperative pain, antimicrobial efficacy, root canal irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Root canal irrigation with co-amoxiclav-clindamycin solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Root canal irrigation with MTAD
Arm Type
Experimental
Arm Description
Irrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one.
Arm Title
Root canal irrigation with 2.5% sodium hypochlorite
Arm Type
Active Comparator
Arm Description
Irrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one.
Intervention Type
Combination Product
Intervention Name(s)
co-amoxiclav-clindamycin solution
Intervention Description
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
Intervention Type
Combination Product
Intervention Name(s)
MTAD
Other Intervention Name(s)
BioPure MTAD
Intervention Description
mixture of 3% doxycycline hyclate, 4.25% citric acid and detergent (Tween 80) to be used as a root canal irrigating solution
Intervention Type
Combination Product
Intervention Name(s)
2.5% sodium hypochlorite
Intervention Description
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
Primary Outcome Measure Information:
Title
postoperative pain: numerical rating scale
Description
intensity of pain by numerical rating scale from 0 to 10
Time Frame
up to 48 hours after the first visit
Secondary Outcome Measure Information:
Title
intra-canal bacterial count
Description
pre and post-instrumentation samples to count intra-canal bacteria (CFU/mL)
Time Frame
72 hours after root canal preparation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel K Elias, M.Sc.
Phone
+2 0122 553 5090
Email
michel.karam.5@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heba El-Asfouri, Ph.D.
Phone
+2 0100 527 6232
Email
heba.elasfouri@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel K Elias, M.Sc.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maged M Negm, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heba El-Asfouri, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Endodontic Department - Faculty of Dentistry - Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Irrigation With Antibiotic-containing Solutions on Postoperative Pain and Intra-canal Bacteria

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