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Effect of two splint designs on patients with jaw joint disorder assessed by change in salivary biomarkers and pain scale.

Effect of maxillary stabilisation splint and plain hard splint on salivary biomarkers and pain in patients with temporomandibular disorder: A randomised control trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097444
Enrollment
20
Registered
2025-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: M266- Temporomandibular joint disorders Health Condition 2: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: Maxillary stabilisation splint: Worn at night for 8 weeks Control Intervention1: Plain hard splint: Worn at night for 8 weeks

Sponsors

Dr Nassiha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pain in the temporomandibular joint area and surrounding muscles persisting for at least 3 months, occurring on at least 4 days a week, not responding to pharmacotherapy of NSAIDs and muscle relaxants.

Exclusion criteria

Exclusion criteria: History of neurological or psychological illnesses, conditions that can influence the pain sensitivity, including chronic widespread pain, systemic muscular or joint disease autoimmune diseases, Use of drugs that affect saliva secretion (e.g., calcium channel blockers, antidepressants, anti-histamines); Pregnancy or lactation, Smoking, Diseases of the salivary glands; Complete edentulism, Untreated mental health disorders or those under active treatment for depression, anxiety, or post-traumatic stress disorder.

Design outcomes

Primary

MeasureTime frame
Change in salivary cortisol and interleukin. Change in pain level(VAS score).Timepoint: Baseline and at 8th week of therapy

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Indu Raj

Government dental college, Kottayam, Kerala

drinduraj17@gmail.com9446461112

Outcome results

None listed

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