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Trauma From OcclusionNCT06999889

Comparative Evaluation of Periodontal Status and Periodontal Parameters in Different Age Group Individuals With and Without Trauma From Occlusion.

An observational study of Trauma From Occlusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Trauma from occlusion (TFO) is defined as an injury resulting in tissue changes within the attachment apparatus as a result of occlusal forces (Glossary of Periodontic Terms American Academy of Periodontology, 2001) This clinical condition is frequently associated with jiggling forces and results in progressive tooth… Read more about this study

Who is it for?
Ages 26 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Trauma From Occlusion
What is being tested?
Recording of Periodontal Parameters.
How many people
208 participants
Where
1 siteIndia
Study dates
Jun 2025to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 26 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Systemically Healthy Individuals in Age Group 26-35 Yrs and 36-45Yrs.

Who may be able to join

None listed.

Who cannot join

  • Any systemic disease which influence the periodontal tissue such as diabetes mellitus.
  • Systemic condition such as Pregnancy and Lactation.
  • Systemic Medication for the past 6 months.
  • Patients undergoing orthodontic treatment or treated cases.
  • Any missing anterior either maxillary or Mandibular teeth.
  • History of systemic antibiotics within last 3 months
Show all 15Show fewer
  • Periapical pathology in anterior teeth.
  • Any periodontal treatment within 6 months prior to study
  • Any developmental anomaly of anterior teeth.
  • Presence of prosthesis in Anterior teeth (Crown and Implant)
  • No vertical stops due to missing posterior teeth.
  • Patients with tongue thrusting habit.
  • Patients with parafunction like Bruxism and Clenching Identified through Interview and occlusal examination.
  • Patient with Oral Habits like Biting or Holding Objects between the Teeth.
  • Patient having any craniomandibular dysfunction or undergone any treatment for temporomandibular joint.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shikha Tewari, MDS contact

91-9416514600

drshikhatewari@yahoo.com

Sanjay Tewari, MDS contact

01262-297876

principal.pgids@uhsr.ac.in

India1 site
  • Department of Periodontology ,Post Graduate Institute Of Dental Sciences

    Rohtak, Haryana, 124001

    Shikha Tewari, MDS, 91-9416514600, drshikhatewari@yahoo.com

    Sanjay Tewari, MDS, +917207738713, principalpgids@yahoo.in

Other trials in India

About this study

Official title: Comparative Evaluation Of Periodontal Parameters And Periodontal Status In Individuals Of Different Age Groups With And Without Trauma From Occlusion: A Cross Sectional Study

Trauma from occlusion (TFO) is defined as an injury resulting in tissue changes within the attachment apparatus as a result of occlusal forces (Glossary of Periodontic Terms American Academy of Periodontology, 2001) This clinical condition is frequently associated with jiggling forces and results in progressive tooth mobility.Experiments performed in animals like the beagle dog showed some periodontal tissue reactions to increasing tooth mobility. Such as (i) Increase in the width of the periodontal ligament area (ii)Increase in the vascularity,vascular permeability and the migration of leukocytes from the vascular plexus and (iii) the increase in number of osteoclasts lining the marginal alveolar bone of the zone of co destruction . Also, the teeth showing increasing mobility exhibit an enhanced rate of periodontal tissue destruction when exposed to experimentally induced periodontitis When trauma from occlusion is the result of alterations in occlusal forces, it is called as primary trauma from occlusion. When it results from the reduced ability of the Periodontal tissues to resist the occlusal forces ,it is known as secondary trauma from occlusion.One of the clinical sign of TFO include presence of Fremitus which means functional tooth mobility.Aggravation of plaque- related inflammatory periodontal disease by trauma from occlusion is still under question.It is unclear whether TFO occurs primarily in periodontitis patients, or bone loss due to periodontitis leads to TFO in later stages. Review of Literature has further revealed that there is no study conducted on anterior teeth with Fremitus and its relation with periodontal parameters.So, it may be hypothesized that TFO may have impact on Periodontal tissue in different age groups as periodontitis is chronic in nature and time of initiation of the disease could not be identified.Periodontitis is chronic in nature and time of initiation of the disease could not be identified. Recently age dependent distribution of periodontitis was studied and findings reported mean clinical attachment loss increased linearly with age and recession contributed increasingly to CAL with age specially after 45-49years.Therefore reduced periodontium in later stages it may lead to TFO, as compared to early stages of life

Read the detailed description

Trauma from occlusion (TFO) is defined as an injury resulting in tissue changes within the attachment apparatus as a result of occlusal forces (Glossary of Periodontic TermsAmerican Academy of Periodontology, 2001) This clinical condition is frequently associated with jiggling forces and results in progressive tooth mobility.Experiments performed in animals like the beagle dog showed some periodontal tissue reactions to increasing tooth mobility. Such as (i) Increase in the width of the periodontal ligament area (ii)Increase in the vascularity,vascular permeability and the migration of leukocytes from the vascular plexus and (iii) the increase in number of osteoclasts lining the marginal alveolar bone of the zone of codestruction . Also, the teeth showing increasing mobility exhibit an enhanced rate of periodontal tissue destruction when exposed to experimentally induced periodontitis When trauma from occlusion is the result of alterations in occlusal forces, it is called as primary trauma from occlusion. When it results from the reduced ability of the Periodontal tissues to resist the occlusal forces ,it is known as secondary trauma from occlusion.One of the clinical sign of TFO include presence of Fremitus which means functional tooth mobility. A tooth with fremitus has excess contact, possibly related to a premature contact during habitual centric closure and excursive mandibular movements.The role of trauma from occlusion in periodontal disease relies on the belief that excessive occlusal forces do not initiate destructive chronic periodontitis .Though these forces are capable of causing periodontal injury and To establish relation between trauma from occlusion and periodontitis both should be present in destructive stages otherwise combined lesion can't be reproduced.Primary trauma from occlusion without periodontal inflammation results in no loss of attachment, with preservation of a bone matrix that is able to regenerate in the absence of traumatogenic forces. However, when periodontal inflammation is superimposed with trauma from occlusion, alterations in alveolar bone height and volume are not reverted by elimination of traumatogenic forces, with persistence of clinical mobility and gingival inflammation .Aggravation of plaque- related inflammatory periodontal disease by trauma from occlusion is still under question, and further investigations are necessary to elucidate such an association.It is unclear whether TFO occurs primarily in periodontitis patients, or bone loss due to periodontitis leads to TFO in later stages. Review of Literature has further revealed that there is no study conducted on anterior teeth with Fremitus and its relation with periodontal parameters.

So, it may be hypothesized that TFO may have impact on Periodontal tissue in different age groups as periodontitis is chronic in nature and time of initiation of the disease could not be identified. Recently age dependent distribution of periodontitis was studied and findings reported mean clinical attachment loss increased linearly with age and recession contributed increasinginly to CAL with age specially after 45-49years.Therefore reduced periodontium in later stages it may lead to TFO, as compared to early stages of life

Being tested
Recording of Periodontal Parameters.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recording of Periodontal Parameters.Diagnostic test

    Periodontal Parameters recording in terms of various indices,measurements and radiographs.

Study groups in NCT06999889
Study groupRoleWhat they receive
Test Group-1.Patients showing positive fremitus test in Age Group-26-35Yrs.
Receives: Diagnostic Test: Recording of Periodontal Parameters.
Test Group-2.Patients showing positive fremitus test in Age Group-36-45Yrs.
Receives: Diagnostic Test: Recording of Periodontal Parameters.
Control Group-1Patients showing negative fremitus test in Age Group-26-35Yrs.
Receives: Diagnostic Test: Recording of Periodontal Parameters.
Contrl Group-2Patients showing negative fremitus test in Age Group-36-45Yrs.
Receives: Diagnostic Test: Recording of Periodontal Parameters.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Attachment level (CAL) )

    Measured in mm from CEJ

    Measured: average 1 year

  2. Probing Pocket Depth (PPD)

    Measured in mm from free Gingival margin.

    Measured: average 1 year

  3. Interproximal Alveolar Bone level(From CEJ)

    Measured from CEJ

    Measured: average 1 year

  4. Pattern of bone Loss.

    Measured from CEJ

    Measured: average 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999889
Sponsor's protocol ID
Ashish kumar perio
Status last verified
May 2025
First submitted
15 May 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma From Occlusion, 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 0 inclusion and 15 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: opening soon, as of the sponsor's last update on 31 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shikha Tewari, MDS (91-9416514600, drshikhatewari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Attachment level (CAL) ) (time frame: average 1 year). The study lists 4 primary outcomes in all. 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 31 May 2025.

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