Role of salivary biomarkers during fixed appliance treatment

Phase 4

Completed

Conditions: Malocclusion, unspecified, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,

Registration Number: CTRI/2020/12/029660

Lead Sponsor: All India Institute of Medical Sciences Jodhpur

Brief Summary: The aim of the study is to evaluate salivary biomarkers (RANKL/OPG) in orthodontic patients with recent and healed extraction sites during enmasse retraction. Patients will be randomly allocated into two groups using computer generated randomization scheme:

Group 1: Orthodontic force application in recent extraction sites

Group 2: Orthodontic force application in healed extraction sites

Method

After recruitment of patients based on inclusion and exclusion criteria baseline salivary samples will be collected from each patient before bonding (T0). Whole saliva will be processed for clarification by centrifugation. Salivary levels of RANKL and OPG will be measured through an ELISA-based capture assay by using the commercial kits for RANKL human ELISA and OPG ELISA

For Group 1 â€“ Initial Leveling and Alignment will be performed first without extraction of 1st premolar. Once

the patient reaches to 019x25 SS as final alignment wire, salivary samples will be collected (T1).Extraction of 1st premolar will be carried out and on the same day retraction force will be applied. Patient will be recalled for collection of samples of unstimulated whole saliva 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force (T4).

13) For Group 2 â€“ Extraction of 1st Premolar will be done before Leveling and Alignment i.e immediately

after bonding. Once the patient reaches to 019x25 SS as final alignment wire, salivary samples will be

collected (T1). Orthodontic retraction force application will be started.

Patient will be recalled for collection of samples of unstimulated whole saliva 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force (T4).

Level of salivary markers and rate of tooth movement will be then evaluated in the two groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patient requiring extraction of 4 premolars for correction(class II div.1 malocclusion, Bimaxillary protrusion) 2) Patient above 12 years of age 3) Need for fixed appliance therapy involving tooth extractions, good general and periodontal health 4) Good oral hygiene 5) Full permanent dentition including the maxillary second molars.

Exclusion Criteria

1. Pregnancy and lactation 2) Patients who would not give informed consent 3) Patients consuming alcohol or tobacco use.
1. Any systemic condition that could affect periodontal status 5) Previous history of orthodontic treatment 6) Patient with disorders of bone metabolism (e.g., osteoporosis, gastrointestinal diseases related to nutrition and mineral metabolism, endocrine diseases, immunologic disorders, and connective tissue diseases) 7) Patient already under medication for treatment of conditions like heart conditions, joint replacements, hormonal or bisphosphonate antiresorptive therapies, and chronic therapy with heparin or corticosteroids.
1. Patients with developmental anomalies like, cleft lip and palate and other craniofacial abnormalities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary levels of RANKL and OPG will be measured through an ELISA-based capture assay by using the commercial kits (Bioassayâ„¢ technology laboratory) HUMAN RANKL ELISA and OPG ELISA (At Biochemistry laboratory, AIIMS JODHPUR) following the manufacturerâ€™s instructions	concentration will be measured in these time points; before bonding (T0), after levelling and alignment and just before application of retraction force (T1), 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force

Secondary Outcome Measures

Name	Time	Method
Rate of tooth movement will be calculated clinically, in terms of distance between cusp tip of maxillary canines and mesiobuccal cusp tips of maxillary first molars, with the help of vernier caliper	Alginate impression will be taken at given time poins before bonding (T0), after levelling and alignment and just before application of retraction force (T1), 2 weeks after application of retraction force (T2), 6-7 weeks after application of retraction force (T3) and 10-11 weeks after application of retraction force

Trial Locations

Locations (1): All India Institute Of Mediacal Sciences, Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
All India Institute Of Mediacal Sciences, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Dr Vinay Kumar Chugh
Principal investigator
8003996704
drvinaychd@yahoo.com