Evaluation of non-instrumentation endodontic treatment in necrotic primary molars using a modified mixture of three antibiotics with simvastatin
| ISRCTN | ISRCTN12940165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12940165 |
| Secondary identifying numbers | 2851 |
- Submission date
- 07/08/2021
- Registration date
- 13/09/2021
- Last edited
- 04/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The aim of this study is to evaluate the success rate of non-instrumentation endodontic treatment using a modified antibiotic paste of cefexime, ciprofloxacin and metronidazole with simvastatin (an anti-inflammatory, bone regeneration drug) on necrotic (dead) primary molars compared to traditional pulpectomy (complete removal of the pulp of the teeth).
Who can participate?
Children aged 4-8 years old with necrotic primary second lower molars
What does the study involve?
Participants will be randomly divided into two groups to be treated with antibiotics in non-instrumentation endodontic treatment or conventional root canal treatment. All the teeth will be evaluated after 1, 3, 6, and 12 months clinically and 3, 6, and 12 months radiologically (x-ray).
What are the possible benefits and risks of participating?
Because of the complexity of the root canal system in primary molars, long or multiple visits are needed to complete pulpectomy treatment, especially with non-cooperative children. Non-instrumentation endodontic treatment seems to be a good alternative choice to traditional pulpectomy as it's an easier and less time-consuming treatment.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
March 2018 to January 2021
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Walaa Almarji
walaa.marji92@damascusuniversity.edu.sy
Contact information
Scientific
Dental College
Damascus University
Al-Mazzeh Street
Damascus
97009
Syria
 ORCID ID |
0000-0003-4384-9621 |
|---|---|
| Phone | +963 (0)967324771 |
| walaa.marji92@damascusuniversity.edu.sy |
Study information
| Study design | Single-centre interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Patient information sheet in Arabic: https://drive.google.com/file/d/1FiNwH5tskC1Ycgvjg468fXKny86a3gl2/view?usp=sharing |
| Scientific title | Clinical and radiological evaluation of modified triple antibiotic paste and simvastatin in non-instrumentation endodontic treatment of necrotic mandibular primary molars: a randomised controlled clinical trial |
| Study acronym | 3Mixtatin in NIET |
| Study objectives | This study is designed to assess the hypothesis that non-instrumentation endodontic treatment with 3mixtatn can be a good alternative treatment to traditional pulpectomy of necrotic primary molars. |
| Ethics approval(s) | Approved 08/07/2018, Damascus University, Faculty of Dentistry (University of Damascus Dental School, Damascus, Syria; +96390404840; Osama.aljabban@gmail.com), ref: none provided |
| Health condition(s) or problem(s) studied | Necrotic primary molars |
| Intervention | Forty-two necrotic mandibular primary second molars from healthy children aged 4-8 years will be randomly divided into two groups using http://www.randomization.com: Group A: teeth will be treated with 3mixtatin in non-instrumentation endodontic treatment Group B: teeth will be treated with conventional root canal treatment After local anesthesia using mepivicaine hydrochloride 3%, each tooth will be isolated using the rubber dam. The carious lesions will be removed and the access cavity will be prepared with a bur in a high-speed handpiece. In group A the canal orifices will be enlarged with a round bur (1 mm diameter and 2 mm depth). The pulp chamber and the canal orifices will be irrigated with 17% EDTA to remove the smear layer and the dentin permeability increased with chemical solutions and then with physiological serum, followed by irrigation with 10 ml 5.25% sodium hypochlorite to remove the necrotic tissues, then irrigated with physiological serum and finally with chlorhexidine gluconate 0.2%. This irrigation protocol will be administered in both two groups. 3Mixtatin preparation: The three commercially available antibiotics metronidazole, cefixime and ciprofloxacin will be mixed in a ratio of 1:1:1 with 2 mg of simvastatin after removing the coating materials and pulverized by porcelain mortars and pestles. The 3Mixtatin will be mixed with propylene glycol to obtain a creamy mix and placed over the canal orifices and the pulpal floor. The tooth will be sealed with a glass ionomer cement and then restored with a stainless steel crown. In group B conventional root canal treatment will be done using k-files and h-files and using the previously mentioned irrigation protocol in group A. The root canals will be dried with paper points and obturate with zinc oxide eugenol paste using a Lentulo spiral in a low-speed handpiece. The tooth will be sealed with a glass ionomer cement and then restored with a stainless steel crown. All procedures will be administered by a pediatric dentist. All the teeth will be evaluated after 1, 3, 6, and 12 months clinically and 3, 6, and 12 months radiologically. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Clinical success criteria measured by two external examiners at baseline (T0) directly after the treatment, 1 month (T1), 3months (T2), 6 months (T3), and 12 months (T4): 1. Absence of fistula detected visually 2. Absence of painful symptoms measured using The Universal Pain Assessment Tool (UPAT) 3. Absence of pathological tooth mobility assessed by applying alternate pressure on the outer and inner aspects of the crown of the tooth using two hand instruments. The results were recorded using a mobility index. 4. Intact gingival contour detected by palpation Radiographic success criteria measured at baseline (T0), 3 months (T1), 6 months (T2), and 12 months after treatment (T3): 1. Resolution of furication lesion radiolucency analysed on the follow-up radiographs using (Imagej)(fiji) 2019 software 2. Absence of pathological bone resorption assessed by detecting any new radiolucency on radiographs 3. Absence of pathological root resorption analysed on the follow-up radiographs using (Imagej)(fiji) 2019 software |
| Secondary outcome measures | The duration of treatment in each group, recorded directly after the treatment |
| Overall study start date | 05/03/2018 |
| Completion date | 15/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 44 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Child aged 4-8 years old with no systemic diseases 2. Necrotic primary second lower molars with signs or symptoms of loss of vitality: buccal swelling or sinus, pathological mobility, bifurcation or periapical radiolucency, pathological root resorption |
| Key exclusion criteria | 1. Non-restorable teeth 2. Excessive root resorption involving more than half of the root 3. Perforation of the pulpal floor 4. Facial cellulitis cases 5. Noncooperative patient 6. Patient with history of allergy to one of the used drugs 7. Patient with systemic disease |
| Date of first enrolment | 05/09/2018 |
| Date of final enrolment | 18/05/2020 |
Locations
Countries of recruitment
- Syria
Study participating centre
Al-Mazzeh Street
Damascus
-
Syria
Sponsor information
University/education
Dental College
Al-Mazzeh Street
Damascus
97009
Syria
| Phone | +963 (0)11 33923000 |
|---|---|
| president@damasuniv.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol and statistical analysis plan aren't available yet. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2024 | 04/10/2024 | Yes | No |
Editorial Notes
04/10/2024: Publication reference added.
09/09/2021: Trial's existence confirmed by Damascus University.
