title: Clinical Efficacy of a Mouth-Exercising Device Adjunct to Local Ointment Intra-Lesional Injections and Surgical Treatment for Oral Submucous Fibrosis: a Randomized Controlled Trial.
abstract: BACKGROUND
  Oral physiotherapy or mouth exercise is considered to be an adjunct but mandatory treatment modality for oral submucous fibrosis (OSMF). This study planned to evaluate the clinical efficacy of a newly designed mouth exercising device (MED) in OSMF patients receiving local ointment, intra-lesional drugs and surgical treatment.
  
  
  METHODS
  A total of 231 OSMF patients were selected and treated with basic regime including topical corticosteroids, oral antioxidants and the icecream-stick exercise regime and allotted randomly to two equal groups A and B. Group-A patients were additionally given MED. Subgroups A1 and B1 patients with an inter-incisal distance (IID) 20-35mm were not given any additional therapy; subgroup A2 and B2 patients (IID 20-35mm) were treated additionally with intra-lesional injections. Subgroups A3 and B3 with IID<20mm were managed surgically. IID was measured at baseline and at 6 months recall. The change in IID measurements was calculated and statistically analyzed using 2-way ANOVA and Tukeys multiple post hoc analysis.
  
  
  RESULTS
  Average improvement in IID after six months of recall visits was observed to be 8.4 mm in subgroup-A1 (n-53) compared to 5.5 mm in B1(n-50) (p<0.01). The IID improvement in subgroup-A2 was found to be 9.3mm (n-46) compared to 5.1 mm in B2 (n-48) (p<0.01). In the surgery group, mouth opening improvement was observed to be 9.6 mm in subgroup A3 (n-18) compared to 4.8 mm for B3 (n-16) (p<0.01).
  
  
  CONCLUSIONS
  Use of the MED appears to be effective for increasing oral opening in OMSF patients in conjunction with local, injection and/or surgical treatment.
authors.affiliation: Division of Clinical Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia E-mail : pravinandsmita@yahoo.co.in.
authors.forename: Pravinkumar
authors.initials: P
authors.lastname: Patil
authors.forename: Vinay
authors.initials: V
authors.lastname: Hazarey
authors.forename: Rekha
authors.initials: R
authors.lastname: Chaudhari
authors.forename: Smita
authors.initials: S
authors.lastname: Nimbalkar-Patil
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D000975:Antioxidants / Q000008:administration & dosage*; D002990:Clobetasol / Q000008:administration & dosage*; D005081:Exercise Therapy / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008297:Male; D009824:Ointments / Q000008:administration & dosage*; D009914:Oral Submucous Fibrosis / Q000188:drug therapy / Q000628:therapy*; D009969:Orthodontic Wires / Q000706:statistics & numerical data*; D011379:Prognosis; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000975:Antioxidants; D009824:Ointments; D002990:Clobetasol