Evaluation of non-instrumentation endodontic treatment in necrotic primary molars using a modified mixture of three antibiotics with simvastatin

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12940165

Enrollment

Registered

2021-09-13

Start date

2018-09-05

Completion date

Unknown

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotic primary molars Oral Health

Interventions

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 wit

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
The duration of treatment in each group, recorded directly after the treatment	—

Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026