Dental Pulp Necrosis, Periapical Diseases, Dental Caries, Primary Teeth
Conditions
Keywords
Lesion Sterilization and Tissue Repair, Dental Pulp Necrosis, Calcium Hydroxide-Iodoform Paste, Modified Triple Antibiotic Paste, Necrotic Primary Teeth
Brief summary
This randomized clinical trial aims to compare the clinical and radiographic success of calcium hydroxide-iodoform paste and modified triple antibiotic paste when used for the treatment of necrotic primary molars in children using the lesion sterilization and tissue repair (LSTR) technique. The study will include children aged 4-7 years with restorable necrotic mandibular second primary molars. Participants will be randomly assigned to receive LSTR treatment with either calcium hydroxide-iodoform paste or modified triple antibiotic paste. Clinical and radiographic findings will be assessed during follow-up over 12 months to determine the success of each treatment. The study hypothesis is that there will be a difference in the clinical and radiographic success between the two treatment materials when used with the LSTR technique
Detailed description
Necrotic primary teeth may present a clinical challenge in pediatric dentistry, particularly when the tooth is restorable and preservation of the primary tooth is desirable until its normal exfoliation. Infection of the root canal system may be associated with clinical and radiographic signs of periapical or furcation involvement. Conventional pulpectomy can be effective in the management of necrotic primary teeth; however, it may be technically demanding in young children because of the complex anatomy of primary molars, limited cooperation, and difficulties associated with instrumentation and obturation. Lesion Sterilization and Tissue Repair (LSTR) is a minimally invasive approach that aims to control infection within the root canal system through the local application of antimicrobial agents, with minimal or no mechanical instrumentation of the canals. The rationale of LSTR is based on the polymicrobial nature of endodontic infection and the ability of antimicrobial materials to reduce or eliminate microorganisms within the infected root canal system. Following reduction of the microbial load, healing of the affected periradicular tissues may occur. Calcium hydroxide-iodoform paste is an antimicrobial root canal filling material that combines the antibacterial properties of calcium hydroxide with the radiopacity and antimicrobial properties of iodoform. It has been widely used in primary tooth endodontic treatment because of its antimicrobial activity, radiopacity, and resorbability characteristics. Modified triple antibiotic paste is another antimicrobial approach consisting of a combination of antibiotics intended to provide activity against a broad range of microorganisms associated with endodontic infections. The present study is designed as a randomized clinical trial to compare these two antimicrobial materials when used as part of the LSTR technique for the management of necrotic primary molars. The study will evaluate whether the use of calcium hydroxide-iodoform paste provides clinical and radiographic outcomes comparable to or different from those achieved with modified triple antibiotic paste. Eligible participants will undergo clinical and radiographic assessment before treatment. Following confirmation of eligibility, participants will be randomly allocated to one of the two treatment groups. The first group will receive LSTR treatment using calcium hydroxide-iodoform paste, while the second group will receive LSTR treatment using modified triple antibiotic paste. Clinical and radiographic assessments will subsequently be performed during the predefined follow-up period. The primary purpose of the study is to determine and compare the clinical and radiographic success of the two treatment approaches over the follow-up period. Clinical assessment will focus on the presence or absence of signs and symptoms associated with the treated tooth, while radiographic assessment will evaluate the status of the periradicular and furcation tissues and any changes in the pre-existing radiographic findings. The study is intended to provide clinical evidence regarding the use of calcium hydroxide-iodoform paste as an alternative antimicrobial material for LSTR treatment of necrotic primary molars. The findings may contribute to the evidence base regarding minimally invasive treatment approaches for infected primary teeth and may help inform clinical decision-making in pediatric dentistry.
Interventions
Calcium hydroxide-iodoform paste will be used as the antimicrobial material for lesion sterilization and tissue repair (LSTR) treatment of necrotic primary molars. Following access to the pulp chamber and the clinical procedures specified in the study protocol, the paste will be placed into the prepared pulp chamber/canal orifices according to the standardized LSTR technique. The tooth will then be restored according to the study protocol. Participants will undergo clinical and radiographic follow-up for 12 months to assess treatment success.
Modified triple antibiotic paste will be used as the antimicrobial material for lesion sterilization and tissue repair (LSTR) treatment of necrotic primary molars. The paste will be prepared and applied according to the standardized formulation and clinical protocol specified in the study. Following access to the pulp chamber and the clinical procedures specified in the study protocol, the paste will be placed according to the LSTR technique. The tooth will then be restored according to the study protocol. Participants will undergo clinical and radiographic follow-up for 12 months to assess treatment success.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to treatment allocation. The care provider administering the intervention will not be blinded because knowledge of the assigned treatment material is required for treatment administration
Intervention model description
This is a prospective, parallel-group, randomized clinical trial with a 1:1 allocation ratio. Participants will be randomly assigned to one of two treatment groups and followed prospectively for 12 months.
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 4-7 years * Positive parental informed consent * Restorable necrotic mandibular second primary molars with peri-radicular/furcal involvement and/or pathologic root resorption (external or internal one-third to two-thirds of the root) * Presence of chronic apical abscess or sinus tract or furcation radiolucency
Exclusion criteria
* Medically compromised patient * Children with a known allergy to any of the components being utilized * Molars near exfoliation * Molars with severely resorbed roots more than two thirds, indicated for extraction * Molar with insufficient coronal structure disabling proper coronal seal * Presence of a periapical or interradicular radiolucent area which could compromise the permanent tooth bud
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Mobility | Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative | Tooth mobility will be assessed using Miller's Mobility Index, ranging from Grade 0 to Grade 3. Grade 0 indicates no clinically detectable mobility, while Grade 1 indicates slight horizontal mobility, Grade 2 indicates moderate horizontal mobility, and Grade 3 indicates severe mobility with both horizontal and vertical displacement. Higher grades indicate greater severity of pathological tooth mobility |
| Soft Tissue Pathologies | Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative | Soft tissue pathologies will be assessed clinically by visual examination for the presence or absence of swelling, abscess, sinus tract, or fistula associated with the treated tooth. Each finding will be recorded as present or absent |
| Pain on Percussion | Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative | Pain on percussion will be assessed clinically using a percussion test of the treated tooth. The response will be recorded as binary, indicating whether pain on percussion is present or absent. |
| Postoperative Pain | Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative | Postoperative pain will be assessed by verbally questioning the participant regarding the presence of pain following treatment. The response will be recorded as binary, indicating whether postoperative pain is present or absent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiolucency at the periapical or furcation area | Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative | Radiolucency in the periapical or furcation area will be assessed using standardized digital radiographs analyzed with DIGORA for Windows software. The finding will be recorded as binary, indicating whether periapical or furcation radiolucency is present or absent |
| Internal or External Root Resorption | Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative | Internal or external root resorption will be assessed using standardized digital radiographs analyzed with DIGORA for Windows software. Root resorption will be recorded as binary, indicating whether internal or external root resorption is present or absent |
Contacts
CONTACTYasmine Gamal Hafez Dawood Ghazaly, B.D.S faculty of dentistry
CONTACTProf.Dr.Osama EL Shahawy Chief supervisor, PhD
PRINCIPAL_INVESTIGATORProf.Dr.Rania Abdullah Nasr, PhD
Faculty of dentistry , Cairo university , Cairo , Giza , Egypt , 12613
Outcome results
None listed