RelapseNCT06456827
''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 ''
A study testing Bite force and Gcf in people with Relapse and Bite Force, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Long-term studies have shown that various occlusal changes occur after the active phase of orthodontic treatment. some of these changes are unwanted changes and are considered as relapse The retention appliances are used to maintain the arch dimensions and alignment of the teeth after completion of the orthodontic… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapse, Bite Force, Biomarker
- What is being tested?
- Bite force and Gcf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 25 Dec 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non - growing (18-25) patients who had finished Fixed orthodontic cases ( ready for debonding )with FMA of 26 or more for hyperdivergent cases and FMA of 24 or less for hypodivergent cases
- Optimal functional occlusion at end of treatment (PAR score >70%).
- Littles irregularity index (Pre-treatment <6mm in both upper and lower arch).
- Nonsurgical and non-orthopedic patients and non syndromic patients.
- Optimal periodontal condition and Good oral hygiene (probing depth <3mm, gingival index score <1
- Good compliance regarding retainer wear
Who cannot join
- Subjects with incomplete orthodontic treatment.
- TMJ disorder patients.
- Any systemic disease affecting bone and general growth.
- Patients with incomplete records.
- Patient who fail to follow up or undergo complete treatment.
- Patient with learning difficulties
- Patients having antibiotic therapy within previous 3 months and used anti -inflammatory drugs in the month before the study
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr Rekha
Rohtak, Haryana, 124001
dr manisha, 9215650617, mk3pgids@gmail.com
About this study
Long-term studies have shown that various occlusal changes occur after the active phase of orthodontic treatment. some of these changes are unwanted changes and are considered as relapse The retention appliances are used to maintain the arch dimensions and alignment of the teeth after completion of the orthodontic treatment. One indicator of the functional state and health of the masticatory system is maximum voluntary bite force (MVBF). Its values vary in accordance to the location of measurement (highest at the first molar, lower at the incisors). People with pronounced horizontal craniofacial growth have somewhat higher values of MVBF, and those with vertical growth have lower values than do those with an average growth pattern. Clinical case reports and descriptive histologic data exist suggesting that bone and tooth remodeling persist for extended periods after removal of appliance or deactivation. A reflection of bone remodelling can be found in the gingival crevicular fluid (GCF) of moving teeth, with decrease or increase in the concentration of biomarker. This prompted us to evaluate the expression of variation in bone turnover marker levels (CTX-Bone resorption marker and BALP -Bone formation marker ) during the retention period. The International Osteoporosis Foundation (IOF) and International Federation of Clinical Chemistry (IFCC) have recommended C-terminal telopeptide of type I collagen (CTX) as one of the reference for BTMs. Hence, The present trial will be undertaken to assess the changes and compare if there is any difference in bite force and change in level of bone biomarker biomarker CTX type 1 collagen(C-terminal telopeptide of type I collagen and bone specific alkaline phosphatase(BALP) in post orthodontic treatment hypodivergent and hyperdivergent cases using beggs retainer over 12 months of period of retention.
Read the detailed description
The proposed study will be a non-pharmacological, two arm parallel, Prospective, single blind clinical trial to evaluate if there is a difference in retentive characteristics of dentition in two group of post orthodontic treatment patients with vertical growth pattern patients in one group and horizontal growth pattern patients in other group of patients. The present study will be conducted in the Department of Orthodontic and Dentofacial Orthopedics, P.G.I.D.S, Pt. B.D Sharma University of health sciences, Rohtak. The study will be carried out after the institutional approval obtained from ethical committee.
Patient will be allocated to two different study group by the investigator. the data analyst will be blinded regarding the intervention group. The sample size for the proposed study was calculated by using the formula. Total sample size = N = 2σ 2 (Zβ + Zα/2) 2 / (difference of mean )2. sample size of 20 patients was calculated by using the above formula at confidence interval 95% with power 99%.
GROUP 1: patient with vertical growth pattern have who had undergone, fixed orthodontic cases having FMA of 26 0 or more for hyperdivergent cases.
GROUP 2 patient with horizontal growth pattern who had undergone , Fixed orthodontic cases having FMA of 24 o or less for hypodivergent cases.
Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA. These parameters will be charted at T0, T1, T2, T3,T4 for each patient.
T0 - Records will be obtained at the time of retainer delivery T1 - Records will be obtained after 1month of retainer delivery T2 - Records will be obtained after 3 month of retainer delivery T3- Records will be obtained after 6 months of retainer delivery T4- Records will be obtained after 12 months of retainer delivery
Assessment of bite force will be done using bite force measuring device at T0 - Records will be obtained at the time of retainer delivery T1 - Records will be obtained after 1month of retainer delivery T2 - Records will be obtained after3month of retainer delivery T3- Records will be obtained after 6 months of retainer delivery T4- Records will be obtained after 12 months of retainer delivery
- Conditions
- Relapse, Bite Force, Biomarker
- Being tested
- Bite force and Gcf
- Keywords
- CTX and BALP biomarker , Bite force
- Medical subject headings
- Recurrence, Xanthomatosis, Cerebrotendinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bite force and GcfOther
change in bite force will be measured by bite force measuring device at, T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval.
Changes in the following parameters - changes in change in levels of bone turnover markers CTX and BALP using ELISA at T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval
| Study group | Role | What they receive |
|---|---|---|
| vertical grower | Other | Patients belonging to group 1 will be patient with vertical growth pattern who have undergone fixed orthodontic cases and are ready for debonding with FMA of 26 0 or more. Begg's Retainer will be formed by conventional method and delivered within 24 hours of debonding. Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA and compare the bite force Receives: Other: Bite force and Gcf |
| Horizontal grower | Other | Patients belonging to group 2 will be patient with horizontal growth pattern who have undergone Fixed orthodontic cases and are ready for debonding with with FMA Of 24 o or less.Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA and compare the bite force Receives: Other: Bite force and Gcf |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bite force will be measured by bite force measuring device
change in bite force will be measured by bite force measuring device at, T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval.
Measured: 12 months
Secondary outcomes (1)
- changes in change in levels of bone turnover markers
Changes in the following parameters - changes in change in levels of bone turnover markers CTX and BALP using ELISA at T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start25 Dec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelapseStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456827
- Sponsor's protocol ID
- Dr Aaliya
- Status last verified
- Oct 2024
- First submitted
- 8 Jun 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 ''
- ClinicalTrials.gov ID
- NCT06456827
- Acronym / sponsor ID
- Dr Aaliya
- Conditions
- Relapse, Bite Force, Biomarker
- Keywords
- CTX and BALP biomarker , Bite force
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-term studies have shown that various occlusal changes occur after the active phase of orthodontic treatment. some of these changes are unwanted changes and are considered as relapse The retention appliances are used to maintain the arch dimensions and alignment of the teeth after completion of the orthodontic treatment. One indicator of the functional state and health of the masticatory system is maximum voluntary bite force (MVBF). Its values vary in accordance to the location of measurement (highest at the first molar, lower at the incisors). People with pronounced horizontal craniofacial growth have somewhat higher values of MVBF, and those with vertical growth have lower values than do those with an average growth pattern. Clinical case reports and descriptive histologic data exist suggesting that bone and tooth remodeling persist for extended periods after removal of appliance or deactivation. A reflection of bone remodelling can be found in the gingival crevicular fluid (GCF) of moving teeth, with decrease or increase in the concentration of biomarker. This prompted us to evaluate the expression of variation in bone turnover marker levels (CTX-Bone resorption marker and BALP -Bone formation marker ) during the retention period. The International Osteoporosis Foundation (IOF) and International Federation of Clinical Chemistry (IFCC) have recommended C-terminal telopeptide of type I collagen (CTX) as one of the reference for BTMs. Hence, The present trial will be undertaken to assess the changes and compare if there is any difference in bite force and change in level of bone biomarker biomarker CTX type 1 collagen(C-terminal telopeptide of type I collagen and bone specific alkaline phosphatase(BALP) in post orthodontic treatment hypodivergent and hyperdivergent cases using beggs retainer over 12 months of period of retention.
Detailed description
The proposed study will be a non-pharmacological, two arm parallel, Prospective, single blind clinical trial to evaluate if there is a difference in retentive characteristics of dentition in two group of post orthodontic treatment patients with vertical growth pattern patients in one group and horizontal growth pattern patients in other group of patients. The present study will be conducted in the Department of Orthodontic and Dentofacial Orthopedics, P.G.I.D.S, Pt. B.D Sharma University of health sciences, Rohtak. The study will be carried out after the institutional approval obtained from ethical committee.
Patient will be allocated to two different study group by the investigator. the data analyst will be blinded regarding the intervention group. The sample size for the proposed study was calculated by using the formula. Total sample size = N = 2σ 2 (Zβ + Zα/2) 2 / (difference of mean )2. sample size of 20 patients was calculated by using the above formula at confidence interval 95% with power 99%.
GROUP 1: patient with vertical growth pattern have who had undergone, fixed orthodontic cases having FMA of 26 0 or more for hyperdivergent cases.
GROUP 2 patient with horizontal growth pattern who had undergone , Fixed orthodontic cases having FMA of 24 o or less for hypodivergent cases.
Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA. These parameters will be charted at T0, T1, T2, T3,T4 for each patient.
T0 - Records will be obtained at the time of retainer delivery T1 - Records will be obtained after 1month of retainer delivery T2 - Records will be obtained after 3 month of retainer delivery T3- Records will be obtained after 6 months of retainer delivery T4- Records will be obtained after 12 months of retainer delivery
Assessment of bite force will be done using bite force measuring device at T0 - Records will be obtained at the time of retainer delivery T1 - Records will be obtained after 1month of retainer delivery T2 - Records will be obtained after3month of retainer delivery T3- Records will be obtained after 6 months of retainer delivery T4- Records will be obtained after 12 months of retainer delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vertical grower | Other | Other: Bite force and GcfPatients belonging to group 1 will be patient with vertical growth pattern who have undergone fixed orthodontic cases and are ready for debonding with FMA of 26 0 or more. Begg's Retainer will be formed by conventional method and delivered within 24 hours of debonding. Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA and compare the bite force |
| Horizontal grower | Other | Other: Bite force and GcfPatients belonging to group 2 will be patient with horizontal growth pattern who have undergone Fixed orthodontic cases and are ready for debonding with with FMA Of 24 o or less.Changes in levels of bone turnover markers CTX-bone resorption and BALP-bone formation using ELISA and compare the bite force |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non - growing (18-25) patients who had finished Fixed orthodontic cases ( ready for debonding )with FMA of 26 or more for hyperdivergent cases and FMA of 24 or less for hypodivergent cases
- Optimal functional occlusion at end of treatment (PAR score >70%).
- Littles irregularity index (Pre-treatment <6mm in both upper and lower arch).
- Nonsurgical and non-orthopedic patients and non syndromic patients.
- Optimal periodontal condition and Good oral hygiene (probing depth <3mm, gingival index score <1
Key exclusion criteria (7 listed)
- Subjects with incomplete orthodontic treatment.
- TMJ disorder patients.
- Any systemic disease affecting bone and general growth.
- Patients with incomplete records.
- Patient who fail to follow up or undergo complete treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bite force and Gcfchange in bite force will be measured by bite force measuring device at, T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval. Changes in the following parameters - changes in change in levels of bone turnover markers CTX and BALP using ELISA at T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval | Other | Horizontal grower, vertical grower |
Primary outcome
change in bite force will be measured by bite force measuring device
Time frame: 12 months
change in bite force will be measured by bite force measuring device at, T0(at the time of retainer delivery), T1(1 month of retainer delivery), T2(3 months of retainer delivery) and T3 (6 months of retainer delivery) ,T4 (12 months of retainer delivery) time interval.
1 secondary outcome
- changes in change in levels of bone turnover markers
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bite force and Gcf in people with Relapse and Bite Force, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr manisha kukreja, MDS (9215650617, mk3pgids@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in bite force will be measured by bite force measuring device (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.