Resorption of Tooth or RootPhase 3LSTRNCT05116306
Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic Paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars
A Phase 3 study testing Hyaluronic acid and Propylene glycol in people with Resorption of Tooth or Root, run by Ain Shams University.
Trial summary
Lesion sterilization and tissue repair therapy technique will be used in primary molars with root resorption using Hyaluronic acid as a vehicle for the double antibiotic therapy in comparison to the conventional technique using propylene glycol vehicle Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Resorption of Tooth or Root
- What is being tested?
- Hyaluronic acid and Propylene glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who have a Primary molar with non-vital pulp.
- Adequate restorable tooth structure for further placement of stainless-steel crowns posttreatment.
- Inflammatory root resorption less than one half as assessed from radiographic evaluation with healthy contralateral tooth
- Teeth showing furcation radiolucency without involving the underlying tooth germ.
Who cannot join
- Primary molars with pulpal floor perforation.
- Patients with a history of drug allergy to metronidazole, ciprofloxacin.
- Inflammatory root resorption more than one half as assessed from radiographic evaluation with healthy contralateral tooth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic Paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars (Randomized Clinical Trial and In Vitro Study)
Lesion sterilization and tissue repair therapy technique will be used in primary molars with root resorption using Hyaluronic acid as a vehicle for the double antibiotic therapy in comparison to the conventional technique using propylene glycol vehicle
Read the detailed description
Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars(Randomized Clinical Trial and In Vitro Study) Introduction LSTR is an acronym for lesion sterilization and tissue repair. It is a process which allows the use of a combination of antibiotics (metronidazole, ciprofloxacin, and minocycline) mixed with propylene glycol gel as a vehicle for controlling of oral infections such as dentinal, pulpal, and periapical lesions. This therapy aims to eliminate causative bacteria from the diseases by disinfecting the lesions and promoting tissue regeneration by the host's natural tissue recovering process. Three types of antibiotics are combined to ensure complete removal of all pathogenic microorganisms in pulpal and periapical lesions.
Hyaluronic acid (HA) is a key element in the soft periodontal tissues, gingiva, and periodontal ligament, and in the hard tissue, such as alveolar bone and cementum Based on the multifunctional roles that HA has in wound healing generally, and that gingival and bone healing follow similar biological principles, it is conceivable that HA has comparable roles in the healing of the mineralized and nonmineralized tissues of the periodontium.
Hence, the purpose of this study is to compare the clinical and radiographic success of a hyaluronic acid and propylene glycol as vehicles for antibiotic in LSTR in primary molars.
Aim of Study A) Primary Objective • The aim of the present study is to evaluate the clinical and radiographic success of hyaluronic acid compared to propylene glycol as vehicles for antibiotics in LSTR for non-vital primary molars.
- Secondary Objectives
- Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application.
PICOTS of the study:
- P - Participants: Children both sexes aged from 5-7 years having pulpally involved non-vital primary molars indicated for extraction.
- I - Intervention: LSTR with hyaluronic acid vehicle
- C - Comparison: LSTR with propylene glycol vehicle (control)
- O -Outcomes: Clinical success: Reduction in pain, abnormal mobility, swelling/abscess Radiographic success: Decrease in interradicular radiolucency and decrease of pathological internal or external root resorption
- T-Time: one year follow up.
- S-Study design: Randomized Clinical Trial Participants, Materials and Methods This study composed of two parts: In vitro part ,as for the hyaluronic acid has two available forms to be used (hyalgan and gengigel), a bacterial swap from non-vital pulp tissue will be taken and bacterial activation of microorganisms will be held on suitable medium according to the bacterial type, the two forms of hyaluronic acid will be mixed with the two antibiotics under study and will be tested for their antibacterial efficacy to determine the best form of hyaluronic acid form to be used in the in vivo part of the study.
In Vitro procedure:
- A sample from a non-vital pulp of primary molar root will be taken by paper point.
- The sample will be cultivated in a suitable medium.
- Bacterial strains will be identified through its medium.
- Each bacterial strain would be isolated and cultivated separately.
- The materials under investigation would be tested over each bacterial strain and inhibition zone diameter will be measured after 24 hours of incubation.
- The form of hyaluronic acid to be used in the in vivo study would be chosen according to the measurement results of the inhibition zones resulted.
II-In Vivo part:
The in vivo part of the study will be conducted as a randomized control trial, with 1:1 allocation ratio to either study group or control group, the RCT is the study design of choice to test the null hypothesis and answer the research question.
Study settings:
The study will be conducted at the outpatient clinic of the department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. This research will be reviewed by the Research Ethics Committee and Institutional Review Board, Faculty of Dentistry, Ain Shams University. A verbal as well as a written consent will be obtained from the caregivers of the participants after explaining the objectives of the study and assuring complete confidentiality of data. All caregivers and participants will be informed that they have the right to withdraw from the study at any time. Moreover, participants 6 years and older will verbally (orally) approve after an age-appropriate explanation of the trial procedures and their objectives.
Recruitment 36 molars will be selected from the outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. Only patients who meet the inclusion criteria and sign the informed consent will be enrolled in the study until the predetermined number of teeth is reached.
Follow up Patients will be recalled for clinical and radiographic follow up after 3, 6 and 12 months.
Clinical evaluation Teeth will be checked for the presence of pain, abscess, or mobility. Radiographic evaluation The amount of furcation radiolucency in comparison to preoperative radiograph Regeneration decrease in radiolucency Static remains the same Increase increase in radiolucency
- Conditions
- Resorption of Tooth or Root
- Being tested
- Hyaluronic acid, Propylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
lesion sterilization and tissue repair technique in non vital primary molars using double antibiotic paste mixed with hyaluronic acid gel
Propylene glycolDrug
lesion sterilization and tissue repair technique in non vital primary molars using double antibiotic paste mixed with Propylene glycol gel
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid group | Experimental | study group Receives: Drug: Hyaluronic acid |
| propylene glycol group | Other | control group Receives: Drug: Propylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by clinical examination
no pain no abnormal mobility no swelling
Measured: one year
radiographic outcome assessed by comparing pre and post treatment periapical radiolucency siz
Decrease in interarticular radiolucency in size as compared to pre operative radiolucency present before treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resorption of Tooth or RootStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, radwa elshakhs, Ain Shams University
- Investigators
- Amira S Badran, PhD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116306
- Sponsor's protocol ID
- PED 21-6D
- Acronym
- LSTR
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic Paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars (Randomized Clinical Trial and In Vitro Study)
- ClinicalTrials.gov ID
- NCT05116306
- Acronym / sponsor ID
- LSTR / PED 21-6D
- Conditions
- Resorption of Tooth or Root
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Nov 2021 (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.
Lesion sterilization and tissue repair therapy technique will be used in primary molars with root resorption using Hyaluronic acid as a vehicle for the double antibiotic therapy in comparison to the conventional technique using propylene glycol vehicle
Detailed description
Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars(Randomized Clinical Trial and In Vitro Study) Introduction LSTR is an acronym for lesion sterilization and tissue repair. It is a process which allows the use of a combination of antibiotics (metronidazole, ciprofloxacin, and minocycline) mixed with propylene glycol gel as a vehicle for controlling of oral infections such as dentinal, pulpal, and periapical lesions. This therapy aims to eliminate causative bacteria from the diseases by disinfecting the lesions and promoting tissue regeneration by the host's natural tissue recovering process. Three types of antibiotics are combined to ensure complete removal of all pathogenic microorganisms in pulpal and periapical lesions.
Hyaluronic acid (HA) is a key element in the soft periodontal tissues, gingiva, and periodontal ligament, and in the hard tissue, such as alveolar bone and cementum Based on the multifunctional roles that HA has in wound healing generally, and that gingival and bone healing follow similar biological principles, it is conceivable that HA has comparable roles in the healing of the mineralized and nonmineralized tissues of the periodontium.
Hence, the purpose of this study is to compare the clinical and radiographic success of a hyaluronic acid and propylene glycol as vehicles for antibiotic in LSTR in primary molars.
Aim of Study A) Primary Objective • The aim of the present study is to evaluate the clinical and radiographic success of hyaluronic acid compared to propylene glycol as vehicles for antibiotics in LSTR for non-vital primary molars.
- Secondary Objectives
- Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application.
PICOTS of the study:
- P - Participants: Children both sexes aged from 5-7 years having pulpally involved non-vital primary molars indicated for extraction.
- I - Intervention: LSTR with hyaluronic acid vehicle
- C - Comparison: LSTR with propylene glycol vehicle (control)
- O -Outcomes: Clinical success: Reduction in pain, abnormal mobility, swelling/abscess Radiographic success: Decrease in interradicular radiolucency and decrease of pathological internal or external root resorption
- T-Time: one year follow up.
- S-Study design: Randomized Clinical Trial Participants, Materials and Methods This study composed of two parts: In vitro part ,as for the hyaluronic acid has two available forms to be used (hyalgan and gengigel), a bacterial swap from non-vital pulp tissue will be taken and bacterial activation of microorganisms will be held on suitable medium according to the bacterial type, the two forms of hyaluronic acid will be mixed with the two antibiotics under study and will be tested for their antibacterial efficacy to determine the best form of hyaluronic acid form to be used in the in vivo part of the study.
In Vitro procedure:
- A sample from a non-vital pulp of primary molar root will be taken by paper point.
- The sample will be cultivated in a suitable medium.
- Bacterial strains will be identified through its medium.
- Each bacterial strain would be isolated and cultivated separately.
- The materials under investigation would be tested over each bacterial strain and inhibition zone diameter will be measured after 24 hours of incubation.
- The form of hyaluronic acid to be used in the in vivo study would be chosen according to the measurement results of the inhibition zones resulted.
II-In Vivo part:
The in vivo part of the study will be conducted as a randomized control trial, with 1:1 allocation ratio to either study group or control group, the RCT is the study design of choice to test the null hypothesis and answer the research question.
Study settings:
The study will be conducted at the outpatient clinic of the department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. This research will be reviewed by the Research Ethics Committee and Institutional Review Board, Faculty of Dentistry, Ain Shams University. A verbal as well as a written consent will be obtained from the caregivers of the participants after explaining the objectives of the study and assuring complete confidentiality of data. All caregivers and participants will be informed that they have the right to withdraw from the study at any time. Moreover, participants 6 years and older will verbally (orally) approve after an age-appropriate explanation of the trial procedures and their objectives.
Recruitment 36 molars will be selected from the outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. Only patients who meet the inclusion criteria and sign the informed consent will be enrolled in the study until the predetermined number of teeth is reached.
Follow up Patients will be recalled for clinical and radiographic follow up after 3, 6 and 12 months.
Clinical evaluation Teeth will be checked for the presence of pain, abscess, or mobility. Radiographic evaluation The amount of furcation radiolucency in comparison to preoperative radiograph Regeneration decrease in radiolucency Static remains the same Increase increase in radiolucency
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid group | Experimental | Drug: Hyaluronic acidstudy group |
| propylene glycol group | Other | Drug: Propylene glycolcontrol group |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients who have a Primary molar with non-vital pulp.
- Adequate restorable tooth structure for further placement of stainless-steel crowns posttreatment.
- Inflammatory root resorption less than one half as assessed from radiographic evaluation with healthy contralateral tooth
- Teeth showing furcation radiolucency without involving the underlying tooth germ.
Key exclusion criteria (3 listed)
- Primary molars with pulpal floor perforation.
- Patients with a history of drug allergy to metronidazole, ciprofloxacin.
- Inflammatory root resorption more than one half as assessed from radiographic evaluation with healthy contralateral tooth.
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 |
|---|---|---|
| Hyaluronic acidlesion sterilization and tissue repair technique in non vital primary molars using double antibiotic paste mixed with hyaluronic acid gel | Drug | hyaluronic acid group |
| Propylene glycollesion sterilization and tissue repair technique in non vital primary molars using double antibiotic paste mixed with Propylene glycol gel | Drug | propylene glycol group |
Primary outcome
Number of participants with treatment-related adverse events as assessed by clinical examination
Time frame: one year
no pain no abnormal mobility no swelling
radiographic outcome assessed by comparing pre and post treatment periapical radiolucency siz
Time frame: one year
Decrease in interarticular radiolucency in size as compared to pre operative radiolucency present before treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Amira S Badran, PhD study chair
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyaluronic acid and Propylene glycol in people with Resorption of Tooth or Root, run by Ain Shams 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 3 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa AE El Shakhs, masters (01223183320, radwaelshakhs@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by clinical examination (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2021.