The Effect of Ca(OH)2 in Apical Periodontitis

NCT04978545 | Completed

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the present study was to determine the intraradicular microbiota of previously root canal-treated teeth with apical periodontitis using droplet digital polymerase chain reaction (ddPCR) and to investigate the antibacterial effectiveness of different intracanal medicaments \[Ca(OH)2 and CHX\] that will make classical chemomechanical preparation more effective. This superiority, parallel, randomized clinical trial was conducted in the clinic of the Endodontic Department, Faculty of Dentistry, Istanbul Medipol University, Istanbul. Sixteen patients with posttreatment apical periodontitis (one tooth each) were randomly allocated into two groups according to the intracanal medicament used (n=8, for each): calcium hydroxide (CH) and 2% chlorhexidine gel (CHX) group. Total bacterial loads, as well as the amount of Enterococcus faecalis (E.faecalis) were determined before (S1) and after (S2) chemomechanical preparation and finally, after intracanal medication (S3) by means of ddPCR.

Conditions

Periapical Periodontitis; Polymerase Chain Reaction; Intracanal Medicament; Enterococcus Faecalis Infection

Outcome Measures

Primary Outcomes (2)

• the sequence analysis of 16S rRNA genes by the Sanger sequencing

  the Sanger sequencing

  change from baseline to postoperative 7 days

• , the quantitation of total bacteria and E.faecalis in 5 different samples (SR1, S1, S2, SR2 and S3) taken from teeth were measured using the ddPCR

  droplet digital PCR

  change from baseline to postoperative 7 days

Study Arms (2)

calciumhydroxide

EXPERIMENTAL

Participants received calciumhydroxide as an intracanal medicament for a one week period

Other: calciumhydroxide, intracanal medicament

chlorhexidine

EXPERIMENTAL

Participants received chlorhexidine gel as an intracanal medicament for a one week period

Other: chlorhexidine, intracanal medicament

Interventions

calciumhydroxide, intracanal medicament OTHER

In the CH group, calcium hydroxide powder (Calxyl; OCO Products, Dirnstein, Germany) was mixed with saline in a ratio 1:1 and the paste was inserted into the canal by using lentulo spirals (Malleifer-Dentsply).

calciumhydroxide

chlorhexidine, intracanal medicament OTHER

, chlorhexidine gel 2% (Gluco-Chex 2% gel, Cerkamed, Stalowa Wola, Polland) was placed into the root canals of this group with an Ultradent Capillary Tip (Ultradent products).

chlorhexidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions
• Teeth with post-treatment apical periodontitis had endodontic therapy completed more than 2 years earlier and required retreatment.
• Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm.
• Termini of the root canal fillings ranged from 0-4 mm short of the radiographic apex, with no overfilling.
• The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity.
• Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm.

You may not qualify if:

• teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth \>4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.

Sponsors & Collaborators

• Seyda Ersahan, DDS, PhD: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Seyda Ersahan, Assoc.Prof.

  IstanbulMedipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Microbial analysis of endodontic infections in teeth with post-treatment apical periodontitis before and after medication

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 27, 2021
• Study Start: January 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2020
• Last Updated: October 3, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: The investigators want to share IPD including all ddPCR results with all researchers

Locations

TU (1)