Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID06456827

Comparative Evaluation of Change in Bite Force and Levels of Bone Turnover Markers CTX and BALP in Hyperdivergent and Hypodivergent Cases During Retention Phases - A Prospective Clinical Trial

Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2024-12-10

40

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how bite force and bone turnover markers change during the retention phase after orthodontic treatment in patients with different vertical facial growth patterns. The study compares patients with vertical (hyperdivergent) and horizontal (hypodivergent) craniofacial growth to understand relapse and bone remodeling processes over a 12-month retention period. This prospective clinical trial aims to provide insights into maintaining teeth alignment using retention appliances after fixed orthodontic treatment. The trial includes two groups of patients who have completed fixed orthodontic treatment and are ready for retainer delivery. Group 1 consists of patients with vertical growth patterns (FMA 26° or more), while Group 2 includes those with horizontal growth patterns (FMA 24° or less). Both groups will receive a Begg's retainer formed conventionally and delivered within 24 hours of debonding. Changes in bite force will be measured using a bite force device, and bone turnover markers CTX (bone resorption) and BALP (bone formation) will be assessed using ELISA at baseline and at 1, 3, 6, and 12 months after retainer delivery. Participants will undergo bite force measurements and biomarker testing at five timepoints during the 12 months retention phase: at retainer delivery, then after 1, 3, 6, and 12 months. Data on bone turnover markers and bite force changes will be collected and compared between the two groups. The study includes monitoring of functional occlusion, oral hygiene, and retainer compliance. The total participation time spans 12 months, during which researchers will assess both clinical and biochemical indicators of bone remodeling and bite function after orthodontic treatment.

CONDITIONS

Brief Title

''Comparative Evaluation of Change in Bite Force and Levels of Bone Turnover Markers CTX and BALP in Hyperdivergent and Hypodivergent Cases During Retention Phases-A Prospective Clinical Trial ''

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 25 years who have completed fixed orthodontic treatment and are ready for retainer delivery
  • Patients with vertical growth pattern (FMA of 26° or more) or horizontal growth pattern (FMA of 24° or less)
  • Optimal functional occlusion at end of treatment (PAR score >70%)
  • Little's irregularity index less than 6 mm in both upper and lower arch before treatment
  • Non-surgical, non-orthopedic, and non-syndromic patients
  • Good periodontal health and oral hygiene (probing depth less than 3 mm, gingival index score less than 1)
  • Good compliance with retainer wear
Not Eligible

You will not qualify if you...

  • Incomplete orthodontic treatment
  • Temporomandibular joint (TMJ) disorders
  • Systemic diseases affecting bone and general growth
  • Incomplete patient records
  • Failure to follow up or complete treatment
  • Learning difficulties
  • Antibiotic therapy within the previous 3 months or anti-inflammatory drug use in the month before the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive retainers after fixed orthodontic treatment and undergo assessments of bite force and bone turnover markers over the retention phase.

5 visits at retainer delivery, 1 month, 3 months, 6 months, and 12 months after retainer delivery

Trial Site Locations

Total: 1 location

1

Dr Rekha

Rohtak, Haryana, India, 124001

Actively Recruiting

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Research Team

D

Dr manisha kukreja, MDS

D

Dr Aaliya khan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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