Assessment of biological markers during root shortening as a part of fixed orthodontic treatment done to intrude the anterior teeth

Not yet recruiting

• Conditions: Abnormal findings on diagnostic imaging and in function studies, without diagnosis,

• Registration Number: CTRI/2023/11/059918
• Lead Sponsor: MES Dental College

Brief Summary

**BACKGROUND-**The studies have shown that MMP-9 is an extracellular proteinase highly expressed in osteoclast as a result of bone resorption during orthodontic tooth movement. Dentin sialophosphoprotein(DSPP) induces secretion of the odontoblast regulatory factor RANKL leading to root resorption. DSPP is cleaved to its two functional domains, Dentin phosphoprotein (DPP) and Dentin sialoprotein (DSP), by matrix metalloproteinase 9 (MMP-9) as reported by Yuan et al in 2012.4 Previous studies have concluded that orthodontic intrusion aggravates root resorption; therefore the purpose of this study is to evaluate change in the levels of MMP-9 with and without orthodontic intrusion with midline mini implants.**NOVELTY-**Even though there are numerous hypotheses stating MMP-9 and its presence as a biomarker in gingival crevicular fluid during bone/root resorption, no such studies have been conducted to prove the hypothesis. There is a lacuna seen in this aspect of research.

**OBJECTIVES-**

**PRIMARY OBJECTIVE-** To observe any correlation of MMP-9 levels in gingival crevicular fluid in two groups of patients treated with and without midline mini implants for intrusion of anterior teeth to the severity of orthodontically-induced external root resorption

**SECONDARY OBJECTIVE-**To compare and evaluate change in the levels of MMP-9 in gingival crevicular fluid in two groups of patients treated with and without midline mini implants for intrusion of anterior teeth at different clinical time-points.To observe any change in the levels of  MMP-9 with respect to age and gender

**METHODOLOGY**

**STUDY DESIGN –** Prospective cohort study

**STUDY SETTING –**      Department of Orthodontics and Dentofacial Orthopedics, MES Dental College, Perinthalmanna.Department of Microbiology, MES Medical College, Perinthalmanna**.**

**STUDY PERIOD AND TIMELINE** -15/09/2023 – 01/01/2024

**STUDY POPULATION-**The sample for this study will include two groups of patients assigned for fixed orthodontic treatment in the Department of Orthodontics and Dentofacial Orthopedics, MES Dental College, Perinthalmanna.

1.**Group 1** – Patients with Angle’s Class I bimaxillary dentoalveolar protrusion malocclusion who will be treated with fixed orthodontic treatment for retraction of anterior teeth following therapeutic extraction of first premolar teeth.

2. **Group 2 –** Patients with Angle’s Class I bimaxillary dentoalveolar protrusion malocclusion with increased visibility of maxillary anteriors >4mm who require simultaneous intrusion and retraction of the anterior segment with a midline Mini implant (Absoanchor, Dentos, 1312 NH 7mm) following therapeutic extraction of first premolar teeth.

**DATA COLLECTION METHOD**

**GCF COLLECTION**

The maxillary incisor teeth (11,12,21,22) where the samples will be collected are first isolated with the cotton rolls and dried with air. The gingival crevicular fluid will be collected by placing PerioPaper strips (Oraflow Inc.Hewlett, New York, USA ) into thegingivalsulcus of maxillary central and lateral incisors. This will be taken from the mesio-buccal and disto-buccal aspect of the gingival sulcus, until a mild resistance is felt and left in place for 30s . Strips contaminated with blood will be excluded. . Samples will always be taken from same sites. All strips with gingival crevicular fluid will be stored in sterile Eppendorf vials containing phosphate-buffered saline. This will be centrifuged for 10 min at 4â° and will be stored at -20â°, in the Department of Microbiology, MES Medical College, Perinthalmanna until all samples are collected.Each aliquot will be thawed to room temperature at the time of test. The samples will be assayed by ELISA Kit with 96T (Shanghai Korain Biotech Co.Ltd Bioassay). All assay procedures will be carried out according to the manufacturer’s instructions. Quantitative analysis will be done at the end of the assay at the Department of Microbiology, MES Medical College, Perinthalmanna.

**RVG**

The images will be analyzed and the Modified Malmgren Grading Criteria  will be used to measure the extent of external apical root resorption

**EXPECTED OUTCOME-**Primary outcome to be measured will be difference in the level of MMP-9 in the two groups of patients at different clinical time-points. Secondary outcome to be observed will be assessment of the extent of root resorption at three months following the start of retraction.

**BENEFITS FROM OUTCOME-**MMP-9 is expressed as an extracellular matrix protein by osteoclast. Its presence often indicates an active bone/root resorption which indicated tooth movement. Bone resorption appears in radiographs at a later stage of treatment. The early detection of MMP-9 in the gingival crevicular fluid occurs at an earlier stage and can be taken as a predictive marker for active bone/tooth resorption.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-11-15
• Study Start: 2023-11-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• 1.Patients with complete dentition apart from third molars 2.Patients in the age group 15 – 30 yrs.
• 3.Group 1 patients will include Patients with Angle’s Class I bimaxillary dentoalveolar protrusion indicated for fixed appliance treatment with therapeutic extraction of first premolar teeth in the maxillary arch.
• 4.Group 2 patients with Angle’s Class I bimaxillary dentoalveolar protrusion indicated for fixed appliance treatment with therapeutic extraction of first premolar teeth in the maxillary arch, with increased visibility of maxillary anteriors >4mm.
• 5.Patients should be having healthy gingival and periodontal status 6.Patients with no radiographic evidence of root resorption after a full mouth radiographic periapical examination.

Exclusion Criteria

1.Missing molars or any of the anterior teeth 2.Previous history of orthodontic treatment 3.Erupted or unerupted supernumeraries in the maxillary anterior segment 4.Impacted canines, Endodontically treated teeth 5.Upper anterior crowding ≥ 4mm 6.Periodontitis 7.History of avulsion or replantation 8.History of prolonged treatment with systemic steroids and NSAIDs 9.History of metabolic disorders.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MMP-9 is expressed as an extracellular matrix protein by osteoclast. Its presence often indicates an active bone/root resorption which indicated tooth movement. Bone resorption appears in radiographs at a later stage of treatment. The early detection of MMP-9 in the gingival crevicular fluid occurs at an earlier stage and can be taken as a predictive marker for active bone/tooth resorption.	TO- Before treatment | T1-Beginning of retraction (6-9months) | T2-Three months after start of retraction (9-12months)

Secondary Outcome Measures

Name	Time	Method
Assessment of the extent of root resorption at three months following the start of retraction.	TO- Before treatment

Trial Locations

Locations (1)

MES Dental College, Perinthalmanna; 🇮🇳 Malappuram, KERALA, India

MES Dental College, Perinthalmanna

🇮🇳Malappuram, KERALA, India

Dr Rishika EK

Principal investigator

08281623919

dr.rishika89@gmail.com