CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Place the freshly prepared calcium hydroxide in to the root canals +3 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05581706
NCT05581706N/ACompleted

The Effects of Calcium Hydroxide and Double Antibiotic Paste on Radiographic Outcomes and Periapical MMP-8 Levels in Regenerative Endodontic Procedures: A Randomized Clinical Trial

Ege University·interventional·Posted Oct 14, 2022·Updated Dec 27, 2023

In Brief

A clinical study evaluating Place the freshly prepared calcium hydroxide in to the root canals, Place the freshly prepared double antibiotic paste in to the root canals, and 2 other interventions for Regenerative Endodontics. Completed, enrolled 23 participants across 1 site.

Detailed Summary

Two-session regenerative endodontic treatment was applied to 20 immature mandibular first molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis. At the end of the first session, calcium hydroxide \[Ca(OH)2\] was applied to 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were applied to the other 10 teeth. The effects of intracanal medicaments on periapical MMP-8 levels were determined by immunofluorometric assay (IFMA) in periapical tissue fluid samples taken from the distal root canal in the first and second sessions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 14, 2022
Enrollment StartSep 1, 2017
Primary CompletionFeb 1, 2020
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 3.7 years ago

Interventions

Place the freshly prepared calcium hydroxide in to the root canalscombination

Calcium hydroxide (Merck, Darmstadt, Germany): prepared by mixing with sterile distilled water and then placed in the coronal 1/3 of the root canals.

Place the freshly prepared double antibiotic paste in to the root canalscombination

Double antibiotic paste (DAP): metronidazole (Flagyl, Sanofi-Aventis, Turkey) and ciprofloxacin (Cipro, Biofarma, Turkey) powdered antibiotics were stored and sealed in airtight containers. The same amount of each drug powder (1:1) was mixed and the mixed samples were combined with sterile distilled water to form an ointment. DAP was introduced in roots canals using a lentulo to fill the entire root canal space.

Taking standart periapical radiography with film holderother

Post-operative periapical radiographs were obtained with Digora Optime SPP system (Soredex Corp., Tuusula, Finland) using intraoral film holders to keep the plates parallel to the long axis of the teeth. A size #2 SPP was used for all exposures. SPPs were exposed with a Gendex Oralix DC dental x-ray unit (Gendex Dental Systems, Milan, Italy) operating at 60 kVp, 7 mA, 0.25 sec. and the plates were scanned immediately after exposure. The clinical and radiographical follow up was performed on 12th months. Image-J program (version 1.47, National Institutes of Health, Bethesda, MD) with TurboReg plug-in (Biomedical Imaging Group, Swiss Federal Institute of Technology, Lausanne, Switzerland) was used to determine the increase in root length, root width, and radiographic root area at 12th month follow up.

Sample collection for immunofluorometric assayother

Periapical exudate samples were collected at the beginning of the RET and at 14th day. MMP-8 levels were measured by immunofluorometric assay (IFMA). Briefly, two monoclonal MMP-8-specific antibodies, 8708 and 8706 (Oy Medix Biochemica Ab, Espoo, Finland) were used as catching antibody and tracer antibody, respectively. Samples were diluted in enzyme buffer (50 mM Tris-HCl, pH 7.5; 0.2 mM NaCl, 1 mM CaCl2). Twenty microlitres of samples and 80 μl of assay buffer (20 mM Tris-HCl, pH 7.5, 0.5 M NaCl, 5 mM CaCl2, 0.5% BSA, 0.05% sodium azide and 20 mg/l diethylenetriaminepentaacetic acid with 2 μg/ml normal mouse serum) were pipetted into the wells. The tracer antibody was labelled using europium chelate. After adding the enhancement solution, fluorescence was measured using a 1234 Delfia Research Fluorometer (Wallac, Turku, Finland).