- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05581706
Regenerative Endodontics Using Different Intracanal Medicaments on Radiographic Outcomes and Periapical MMP-8 Levels
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
Study Overview
Status
Conditions
Intervention / Treatment
- Combination product: Place the freshly prepared calcium hydroxide in to the root canals
- Combination product: Place the freshly prepared double antibiotic paste in to the root canals
- Diagnostic test: Taking standart periapical radiography with film holder
- Other: Sample collection for immunofluorometric assay
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İzmir, Turkey
- Ege University Faculty of Dentistry Pediatric Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy children with irreversible pulpitis with symptomatic apical periodontitis (SIP-SAP), indication for RET and informed consent from the patients.
Exclusion Criteria:
- Children with extra oral swelling or luxation with a deep periodontal pocket and whom application of RET was contraindicated.
- The teeth were indicated for vital pulp therapy (assesed during treatment)
- Children who have used antibiotics in the past 3 months and are uncooperative during treatment
- Children who have used any painkillers during the treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Regenerative endodontic treatment with calcium hydroxide
Regenerative endodontic treatment (RET) performed with procedures of American Association of Endodontics (AAE) in two sessions. At the end of the first session, periapical tissue fluid samples (baseline samples) were collected. Calcium hydroxide medicament was prepared by mixing with sterile distilled water and then placed in the coronal 1/3 of the root canals. In the second session (14 days after first treatment), the medicaments in the root canals were carefully removed with 5 ml sterile distilled water irrigation. Periapical tissue fluid samples were obtained from the distal canal using the same protocol as described previously (final samples). Then RET was finished according to the treatment protocol of AAE. |
Calcium hydroxide (Merck, Darmstadt, Germany): prepared by mixing with sterile distilled water and then placed in the coronal 1/3 of the root canals.
Other Names:
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Active Comparator: Regenerative endodontic treatment with double antibiotic paste
Regenerative endodontic treatment (RET) performed with procedures of American Association of Endodontics (AAE) in two sessions. At the end of the first session, periapical tissue fluid samples (baseline samples) were collected. Double antibiotic paste (DAP) was prepared by mixing same amount of metronidazole and ciprofloxacin powdered antibiotics (1:1) and 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. In the second session (14 days after first treatment) after removal of DAP in the root canals, periapical tissue fluid samples were obtained the same protocol as described previously (final samples). Then RET was finished according to the treatment protocol of AAE. |
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.
Other Names:
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Active Comparator: Radiographic evaluation
Pre-operative, post-operative and final recall (12th months follow up) standart digital radiographs were taken from patients with film holder. The radiographs saved and transferred to Image J software (version 1.47, National Institutes of Health, Bethesda, MD). The standardized radiographs were further aligned using the TurboReg plugin (Biomedical Imaging Group, Swiss Federal Institute of Technology, Lausanne, Switzerland) within the Image J toolkit to minimize any distortions caused by variability in the angulation. All images were calibrated according to size #2 SPP (vertical dimension 31 mm, horizontal dimension 41 mm) using the ''set scale'' option in Image J. Thereafter, the root lengths, root width and radiographic root area were measured on both preoperative and final recall images to evaluate treatment outcomes. |
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.
Other Names:
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Active Comparator: Periapical tissue exudate sample collection and Immunofluorometric assay MMP-8
At the end of the first session, periapical tissue fluid samples (baseline samples) were collected by introducing 3 sterile #45 paper points into the root canal until 2 mm passing through the root apex from the distal canal. After waiting for 1 min, the paper points were withdrawn, the tip was cut from 4 mm and were transferred to sterile Eppendorf tubes. At the beginnign of the second session periapical tissue fluid samples were obtained from the distal canal using the same protocol as described in the first session (final samples). Baseline and final MMP-8 concentrations were determined by a time-resolved immunofluorometric assay (IFMA). The monoclonal MMP-8 specific antibodies 8708 and 8706 (Oy Medix Biochemica Ab, Espoo, Finland) were used as a catching antibody and a tracer antibody, respectively. The tracer antibody was labeled using europium-chelate |
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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical healing according to presence of clinical symptoms
Time Frame: 12 months
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All patients were called for follow up visits.
The clinical healing was determined by examining clinical symptoms including presence of pain, tenderness to percussion and palpation, presence of sinus tract or swelling, and mobility.
All teeth were asymptomatic at follow up appointments.
If one of these symptoms occurred, it could considered as failure.
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12 months
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Periapical healing according to change in amount of root hard tissues
Time Frame: 12 months
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All periapical radiolucency detected due to apical periodontitis were healed.
Significant increases in radiographic root length, root width and RRA was observed at 12th month.
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12 months
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MMP-8 levels from periapical tissue fluid samples
Time Frame: 14 day
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There was a statistically significant increase in MMP-8 levels on day 14 compared to baseline in both Ca(OH)2 and DAP groups.
The increase in MMP-8 levels was higher in the DAP group compared to Ca(OH)2 group, however no statistically significant difference was observed between 2 groups regarding the final (14th day) MMP-8 levels.
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14 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Burç Pekpınarlı, Ege University Faculty of Dentistry
Publications and helpful links
General Publications
- Torabinejad M, Alexander A, Vahdati SA, Grandhi A, Baylink D, Shabahang S. Effect of Residual Dental Pulp Tissue on Regeneration of Dentin-pulp Complex: An In Vivo Investigation. J Endod. 2018 Dec;44(12):1796-1801. doi: 10.1016/j.joen.2018.09.005.
- Sabeti M, Golchert K, Torabinejad M. Regeneration of Pulp-Dentin Complex in a Tooth with Symptomatic Irreversible Pulpitis and Open Apex Using Regenerative Endodontic Procedures. J Endod. 2021 Feb;47(2):247-252. doi: 10.1016/j.joen.2020.09.021. Epub 2020 Oct 10.
- Wahlgren J, Salo T, Teronen O, Luoto H, Sorsa T, Tjaderhane L. Matrix metalloproteinase-8 (MMP-8) in pulpal and periapical inflammation and periapical root-canal exudates. Int Endod J. 2002 Nov;35(11):897-904. doi: 10.1046/j.1365-2591.2002.00587.x.
- Kuula H, Salo T, Pirila E, Tuomainen AM, Jauhiainen M, Uitto VJ, Tjaderhane L, Pussinen PJ, Sorsa T. Local and systemic responses in matrix metalloproteinase 8-deficient mice during Porphyromonas gingivalis-induced periodontitis. Infect Immun. 2009 Feb;77(2):850-9. doi: 10.1128/IAI.00873-08. Epub 2008 Nov 24.
- Bose R, Nummikoski P, Hargreaves K. A retrospective evaluation of radiographic outcomes in immature teeth with necrotic root canal systems treated with regenerative endodontic procedures. J Endod. 2009 Oct;35(10):1343-9. doi: 10.1016/j.joen.2009.06.021. Epub 2009 Aug 15.
- Reynaud af Geijersstam A, Sorsa T, Stackelberg S, Tervahartiala T, Haapasalo M. Effect of E. faecalis on the release of serine proteases elastase and cathepsin G, and collagenase-2 (MMP-8) by human polymorphonuclear leukocytes (PMNs). Int Endod J. 2005 Sep;38(9):667-77. doi: 10.1111/j.1365-2591.2005.01011.x.
- Martinho FC, Nascimento GG, Leite FR, Gomes AP, Freitas LF, Camoes IC. Clinical influence of different intracanal medications on Th1-type and Th2-type cytokine responses in apical periodontitis. J Endod. 2015 Feb;41(2):169-75. doi: 10.1016/j.joen.2014.09.028. Epub 2014 Nov 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Regenerative Endodontics
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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