Clinical trial NCT05581706: Regenerative Endodontics Using Different Intracanal Medicaments on Radiographic Outcomes and Periapical MMP-8 Levels
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regenerative Endodontics
Keywords: regenerative endodontics
intracanal medicaments
MMP-8
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The aim of the study was to investigate the effects of two different intracanal medicaments used during regenerative endodontic treatment (RET) on periapical MMP-8 in relation to the radiological outcomes of RET. After local anesthesia and rubber dam isolation were provided, disinfection procedures were applied gently in accordance with the current RET protocol of American Association of Endodontics (AAE) on the molar teeth. Periapical tissue fluid samples were taken with paper points placed to protrude 2 mm from the distal root canal tip. Calcium hydroxide \[Ca(OH)2\] was placed in 10 randomly selected teeth and double antibiotic paste (DAP) intracanal medicaments were placed in the other 10 teeth. Fourteen days later in the second session, the final sampling procedure was performed as in the first session. Then, the treatment was completed according to the current RET protocol of AAE and permanent restorations were made. The success of the treatment and its effect on root development were evaluated by comparing the standard radiographs taken at the end of the treatment and 12 months follow up. MMP-8 levels were measured by immunofluorometric assay (IFMA) in the periapical tissue fluid samples. First and second session MMP-8 levels were compared according to the groups of medicaments \[Ca(OH)2 and DAP groups\] placed in the root canals.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical healing according to presence of clinical symptoms
timeFrame: 12 months
measure: Periapical healing according to change in amount of root hard tissues
timeFrame: 12 months
measure: MMP-8 levels from periapical tissue fluid samples
timeFrame: 14 day
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Dentistry Pediatric Dentistry
Study officials:
affiliation: Ege University Faculty of Dentistry
name: Burç Pekpınarlı
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.