Dental Pulp NecrosisNCT07773805
Clinical and Radiographic Success of Calcium Hydroxide-Iodoform Paste Versus Modified Triple Antibiotic Paste for Necrotic Primary Molars in Children
A study testing Calcium Hydroxide, Iodoform, paste and modified triple antibiotic paste in people with Dental Pulp Necrosis and Periapical Diseases, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Dental Pulp Necrosis, Periapical Diseases, Dental Caries
- What is being tested?
- Calcium Hydroxide, Iodoform, paste and modified triple antibiotic paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yasmine Gamal Hafez Dawood Ghazaly, B.D.S faculty of dentistry contact
Prof.Dr.Osama EL Shahawy Chief supervisor, PhD contact
About this study
Official title: Assessment of the Clinical and Radiographic Success of Calcium Hydroxide Iodoform Paste Versus Modified Triple Antibiotic Paste for the Treatment of Necrotic Primary Molars Using LSTR Technique: A Randomized Clinical Trial
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
Read the 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.
- Being tested
- Calcium Hydroxide, Iodoform, paste, modified triple antibiotic paste
- Keywords
- Lesion Sterilization and Tissue Repair, Dental Pulp Necrosis, Calcium Hydroxide-Iodoform Paste, Modified Triple Antibiotic Paste, Necrotic Primary Teeth
- Medical subject headings
- Dental Pulp Necrosis, Periapical Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide, Iodoform, pasteDrug
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 pasteDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide-Iodoform Paste + LSTR | Experimental | Participants assigned to this arm will receive lesion sterilization and tissue repair (LSTR) treatment using calcium hydroxide-iodoform paste as the antimicrobial material. The treatment will be performed according to the standardized clinical protocol, followed by clinical and radiographic evaluation during the 12-month follow-up period. Receives: Drug: Calcium Hydroxide, Iodoform, paste |
| Modified Triple Antibiotic Paste + LSTR | Active comparator | Participants assigned to this arm will receive lesion sterilization and tissue repair (LSTR) treatment using modified triple antibiotic paste as the antimicrobial material. The treatment will be performed according to the standardized clinical protocol, followed by clinical and radiographic evaluation during the 12-month follow-up period. Receives: Drug: modified triple antibiotic paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Mobility
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
Measured: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Soft Tissue Pathologies
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
Measured: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Pain on Percussion
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.
Measured: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Postoperative Pain
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
Measured: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Secondary outcomes (2)
Radiolucency at the periapical or furcation area
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
Measured: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Internal or External Root Resorption
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
Measured: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp NecrosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Gamal Hafez Dawood Ghazaly, Cairo University
- Investigators
- Prof.Dr.Rania Abdullah Nasr, PhD, Principal investigator, Faculty of dentistry , Cairo university , Cairo , Giza , Egypt , 12613
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773805
- Sponsor's protocol ID
- CU-PEDO-2026-001
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almarji W, Laflouf M, Tolibah YA. Evaluation of the modified 3Mix-Simvastatin combination in non-instrumental endodontic therapy of necrotic primary molars: A two-arm randomized controlled trial. Clin Exp Dent Res. 2024 Apr;10(2):e860. doi: 10.1002/cre2.860.
PubMed 38433296Thakur S, Deep A, Singhal P, Chauhan D. A randomized control trial comparing the efficacy of 3Mixtatin and Modified 3Mix-MP paste using lesion sterilization and tissue repair technique to conventional root canal treatment in primary molars of children aged 4-8 years: An in vivo study. Dent Res J (Isfahan). 2021 Nov 22;18:93. doi: 10.4103/1735-3327.330874. eCollection 2021.
PubMed 35003558Singh K, Reddy A, Arya A, Sridhar V, Ranjan M, Bulbule N. Lesion Sterilization Tissue Repair: A Review. J Pharm Bioallied Sci. 2024 Feb;16(Suppl 1):S75-S77. doi: 10.4103/jpbs.jpbs_411_23. Epub 2024 Feb 29.
PubMed 38595433Shafi MK, Shah AA, Khan MA, Faisal S, Iqbal S. The Assessment and Efficiency of Cefixime in Upper Respiratory Tract Infections: Insights and Perspectives. Cureus. 2024 Jul 14;16(7):e64539. doi: 10.7759/cureus.64539. eCollection 2024 Jul.
PubMed 39144897Sain S, J R, S A, George S, S Issac J, A John S. Lesion Sterilization and Tissue Repair-Current Concepts and Practices. Int J Clin Pediatr Dent. 2018 Sep-Oct;11(5):446-450. doi: 10.5005/jp-journals-10005-1555. Epub 2018 Oct 1.
PubMed 30787561Sefa I, Garg N, Pathivada L, Yeluri R. Success of Lesion Sterilization and Tissue Repair Therapy and Pulpectomy in the Management of Infected Primary Molars with Poor Prognosis. Int J Clin Pediatr Dent. 2024 Jan;17(1):41-47. doi: 10.5005/jp-journals-10005-2750.
PubMed 38559868Shankar K, Ramkumar H, Dhakshinamoorthy S, Paulindraraj S, Jayakaran TG, Bommareddy CS. Comparison of Modified Triple Antibiotic Paste in Two Concentrations for Lesion Sterilization and Tissue Repair in Primary Molars: An In Vivo Interventional Randomized Clinical Trial. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):388-392. doi: 10.5005/jp-journals-10005-1951.
PubMed 34720512M Ghorpad, T. (2024). Success Rate of Triple Antibiotic Paste for Lesion Sterilization and Tissue Repair Therapy in Primary Molars: A Systematic Review. World Journal of Dentistry, 14(12).
Li L, Yang X, Ju W, Li J, Yang X. Impact of primary molars with periapical disease on permanent successors: A retrospective radiographic study. Heliyon. 2023 Apr 28;9(5):e15854. doi: 10.1016/j.heliyon.2023.e15854. eCollection 2023 May.
PubMed 37187910Govindaraju L, Jeevanandan G, Vishwanathaiah S, Maganur PCG. Clinical and radiographic success rate of the root canal filling materials used in primary teeth: A systematic review. Dent Med Probl. 2024 May-Jun;61(3):447-455. doi: 10.17219/dmp/152235.
PubMed 38963396Estrela C, Estrela CR, Hollanda AC, Decurcio Dde A, Pecora JD. Influence of iodoform on antimicrobial potential of calcium hydroxide. J Appl Oral Sci. 2006 Jan;14(1):33-7. doi: 10.1590/s1678-77572006000100007.
PubMed 19089027Barve A, Lakade L, Shah P, Chaudhary S, Jajoo S, Joshi G. Antibiotic Paste as an Intracanal Medicament in Infected Primary Teeth: A Systematic Review. Cureus. 2025 Apr 23;17(4):e82876. doi: 10.7759/cureus.82876. eCollection 2025 Apr.
PubMed 40416098Amila Zukanović, Elmedin Bajrić, Marković, N., Damir Duratbegović, Katana, E., Emina Čengić, Senka Serhatlić and Hasan Pejak (2023). Lesion sterilization and tissue repair (LSTR) method in irreversible dental pulp changes of primary teeth. Balkan Journal of Dental Medicine, 27(1), pp.15-20. doi:10.5937/bjdm2301015z.
Alrayes N, Almaimouni Y, Tounsi A, Tarabzouni K, Alonaizan F, Salem Ibrahim M. The effect of an antibacterial mixture and non-instrumentation endodontic treatment in primary teeth: A systematic review and meta-analyses. Saudi Dent J. 2023 Sep;35(6):575-588. doi: 10.1016/j.sdentj.2023.06.001. Epub 2023 Jun 19.
PubMed 37823084ali, I., Mohamed Ismai, A. A. D., Abbas, A. (2022). 'Clinical and Radiographic Evaluation of Different Obturating Materials as Biological Barrier in Quality of Obturation of Pulpectomized Primary Anterior Teeth', Al-Azhar Journal of Dental Science, 25(4), pp. 505-515. doi: 10.21608/ajdsm.2022.119687.1301
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical and Radiographic Success of Calcium Hydroxide Iodoform Paste Versus Modified Triple Antibiotic Paste for the Treatment of Necrotic Primary Molars Using LSTR Technique: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07773805
- Acronym / sponsor ID
- CU-PEDO-2026-001
- Keywords
- Lesion Sterilization and Tissue Repair, Dental Pulp Necrosis, Calcium Hydroxide-Iodoform Paste, Modified Triple Antibiotic Paste, Necrotic Primary Teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide-Iodoform Paste + LSTR | Experimental | Drug: Calcium Hydroxide, Iodoform, pasteParticipants assigned to this arm will receive lesion sterilization and tissue repair (LSTR) treatment using calcium hydroxide-iodoform paste as the antimicrobial material. The treatment will be performed according to the standardized clinical protocol, followed by clinical and radiographic evaluation during the 12-month follow-up period. |
| Modified Triple Antibiotic Paste + LSTR | Active comparator | Drug: modified triple antibiotic pasteParticipants assigned to this arm will receive lesion sterilization and tissue repair (LSTR) treatment using modified triple antibiotic paste as the antimicrobial material. The treatment will be performed according to the standardized clinical protocol, followed by clinical and radiographic evaluation during the 12-month follow-up period. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Hydroxide, Iodoform, pasteCalcium 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. | Drug | Calcium Hydroxide-Iodoform Paste + LSTR |
| modified triple antibiotic pasteModified 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. | Drug | Modified Triple Antibiotic Paste + LSTR |
Primary outcome
Pathological Mobility
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Radiolucency at the periapical or furcation area
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Internal or External Root Resorption
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 38433296Almarji W, Laflouf M, Tolibah YA. Evaluation of the modified 3Mix-Simvastatin combination in non-instrumental endodontic therapy of necrotic primary molars: A two-arm randomized controlled trial. Clin Exp Dent Res. 2024 Apr;10(2):e860. doi: 10.1002/cre2.860.
- Background: PubMed 35003558Thakur S, Deep A, Singhal P, Chauhan D. A randomized control trial comparing the efficacy of 3Mixtatin and Modified 3Mix-MP paste using lesion sterilization and tissue repair technique to conventional root canal treatment in primary molars of children aged 4-8 years: An in vivo study. Dent Res J (Isfahan). 2021 Nov 22;18:93. doi: 10.4103/1735-3327.330874. eCollection 2021.
- Background: PubMed 38595433Singh K, Reddy A, Arya A, Sridhar V, Ranjan M, Bulbule N. Lesion Sterilization Tissue Repair: A Review. J Pharm Bioallied Sci. 2024 Feb;16(Suppl 1):S75-S77. doi: 10.4103/jpbs.jpbs_411_23. Epub 2024 Feb 29.
- Background: PubMed 39144897Shafi MK, Shah AA, Khan MA, Faisal S, Iqbal S. The Assessment and Efficiency of Cefixime in Upper Respiratory Tract Infections: Insights and Perspectives. Cureus. 2024 Jul 14;16(7):e64539. doi: 10.7759/cureus.64539. eCollection 2024 Jul.
- Background: PubMed 30787561Sain S, J R, S A, George S, S Issac J, A John S. Lesion Sterilization and Tissue Repair-Current Concepts and Practices. Int J Clin Pediatr Dent. 2018 Sep-Oct;11(5):446-450. doi: 10.5005/jp-journals-10005-1555. Epub 2018 Oct 1.
- Background: PubMed 38559868Sefa I, Garg N, Pathivada L, Yeluri R. Success of Lesion Sterilization and Tissue Repair Therapy and Pulpectomy in the Management of Infected Primary Molars with Poor Prognosis. Int J Clin Pediatr Dent. 2024 Jan;17(1):41-47. doi: 10.5005/jp-journals-10005-2750.
- Background: PubMed 34720512Shankar K, Ramkumar H, Dhakshinamoorthy S, Paulindraraj S, Jayakaran TG, Bommareddy CS. Comparison of Modified Triple Antibiotic Paste in Two Concentrations for Lesion Sterilization and Tissue Repair in Primary Molars: An In Vivo Interventional Randomized Clinical Trial. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):388-392. doi: 10.5005/jp-journals-10005-1951.
- BackgroundM Ghorpad, T. (2024). Success Rate of Triple Antibiotic Paste for Lesion Sterilization and Tissue Repair Therapy in Primary Molars: A Systematic Review. World Journal of Dentistry, 14(12).
- Background: PubMed 37187910Li L, Yang X, Ju W, Li J, Yang X. Impact of primary molars with periapical disease on permanent successors: A retrospective radiographic study. Heliyon. 2023 Apr 28;9(5):e15854. doi: 10.1016/j.heliyon.2023.e15854. eCollection 2023 May.
- Background: PubMed 38963396Govindaraju L, Jeevanandan G, Vishwanathaiah S, Maganur PCG. Clinical and radiographic success rate of the root canal filling materials used in primary teeth: A systematic review. Dent Med Probl. 2024 May-Jun;61(3):447-455. doi: 10.17219/dmp/152235.
- Background: PubMed 19089027Estrela C, Estrela CR, Hollanda AC, Decurcio Dde A, Pecora JD. Influence of iodoform on antimicrobial potential of calcium hydroxide. J Appl Oral Sci. 2006 Jan;14(1):33-7. doi: 10.1590/s1678-77572006000100007.
- Background: PubMed 40416098Barve A, Lakade L, Shah P, Chaudhary S, Jajoo S, Joshi G. Antibiotic Paste as an Intracanal Medicament in Infected Primary Teeth: A Systematic Review. Cureus. 2025 Apr 23;17(4):e82876. doi: 10.7759/cureus.82876. eCollection 2025 Apr.
- Individual participant dataSharing planned: No
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Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasmine Gamal Hafez Dawood Ghazaly, B.D.S faculty of dentistry contact
Prof.Dr.Osama EL Shahawy Chief supervisor, PhD contact
Prof.Dr.Rania Abdullah Nasr, PhD principal investigator
Faculty of dentistry , Cairo university , Cairo , Giza , Egypt , 12613
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxide, Iodoform, paste and modified triple antibiotic paste in people with Dental Pulp Necrosis and Periapical Diseases, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmine Gamal Hafez Dawood Ghazaly, B.D.S faculty of dentistry (+201204444443, yasmine.ghazaly@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Mobility (time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07773805, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.