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Effect of gentle electrical stimulation of nerves in muscles activity of children undergoing removable dental appliance treatment for small backwardly positioned lower jaw with forwardly positioned upper front tooth

Effect of adjunctive transcutaneous electrical nerve stimulation (tens) on electromyographic activity in class II division 1 patients undergoing twin block therapy-a pilot clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089526
Enrollment
18
Registered
2025-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: TENS with Twin block: Transcutaneous Electrical Nerve Stimulation (TENS) can alleviate neuromuscular tension and promote neuromuscular adaptation. When used adjunctively with Twin Block

Sponsors

Nisar P B
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age range of 9 to 14 years irrespective of gender. 2.Patients in CVMI stage CS3 and CS4. 3.Class II division 1 malocclusion cases with crowding less than 6mm in lower arch. 4.Overjet more than 5mm and less than 10mm. 5.Molar relationship at least a half unit Angle Class II. 6.Horizontal and average facial growth pattern with FMA not exceeding 28 degree. 7.Patients with mandibular retrognathism and positive VTO. 8.Patients with no previous orthodontic treatment. 9.Patients with healthy periodontium with no gingival inflammation. 10.Patients without significant medical history. and condition contraindicating use of TENS like seizure, medical implant devices etc. 11.Patients with positive informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients requiring pre-functional orthodontic treatment. 2.Patient with vertical growth pattern. 3.Patients with TMD problems. 4.Patients with dentofacial deformities or syndromes. 5.patients with epilepsy, those with implanted electrical devices, including pacemakers, implantable cardioverter-defibrillators, spinal cord stimulators, sensory motor disorders, skin lesions or wounds etc.

Design outcomes

Primary

MeasureTime frame
To compare the electromyographic (EMG) activity of masseter and anterior temporalis between class II division 1 patients undergoing twin block treatment with class II division 1 patients undergoing twin block and adjunctive Transcutaneous Electrical Nerve Stimulation (TENS).Timepoint: T0 - Baseline recording. T1 - End of First week. T2 - End of first month/fourth week. T3 - End of third month. T4 - End of sixth month.

Secondary

MeasureTime frame
To evaluate the progression of electromyographic (EMG) activity of masseter and anterior temporalis over the course of 6 months of treatment in Class II Division 1 patients undergoing Twin Block therapy, with and without adjunctive TENS.Timepoint: EMG Evaluation 1.Baseline recording before and after inserting twin block 2.End of first week (before and after tens) 3.End of First month/ fourth week (before and after tens) 4.End of Third month 5.End of Sixth month

Countries

India

Contacts

Public ContactRitu Duggal

CDER,AIIMS

rituduggal@rediffmail.com7838390003

Outcome results

None listed

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