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.
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.
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
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
- Conditions
- Trauma From Occlusion
- 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 group | Role | What 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-1 | Patients showing negative fremitus test in Age Group-26-35Yrs. Receives: Diagnostic Test: Recording of Periodontal Parameters. | |
| Contrl Group-2 | Patients 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.
Clinical Attachment level (CAL) )
Measured in mm from CEJ
Measured: average 1 year
Probing Pocket Depth (PPD)
Measured in mm from free Gingival margin.
Measured: average 1 year
Interproximal Alveolar Bone level(From CEJ)
Measured from CEJ
Measured: average 1 year
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.
- First posted31 May 2025
- Study startJun 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma From OcclusionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashish Kumar, BDS, Principal investigator, Post Graduate Institute of Dental Sciences ,Rohtak
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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06999889
- Acronym / sponsor ID
- Ashish kumar perio
- Conditions
- Trauma From Occlusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 May 2025 (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.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group-1. | – | Diagnostic Test: Recording of Periodontal Parameters.Patients showing positive fremitus test in Age Group-26-35Yrs. |
| Test Group-2. | – | Diagnostic Test: Recording of Periodontal Parameters.Patients showing positive fremitus test in Age Group-36-45Yrs. |
| Control Group-1 | – | Diagnostic Test: Recording of Periodontal Parameters.Patients showing negative fremitus test in Age Group-26-35Yrs. |
| Contrl Group-2 | – | Diagnostic Test: Recording of Periodontal Parameters.Patients showing negative fremitus test in Age Group-36-45Yrs. |
Who may qualify
- Ages
- 26 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Systemically Healthy Individuals in Age Group 26-35 Yrs and 36-45Yrs.
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Recording of Periodontal Parameters.Periodontal Parameters recording in terms of various indices,measurements and radiographs. | Diagnostic test | Contrl Group-2, Control Group-1, Test Group-1., Test Group-2. |
Primary outcome
Clinical Attachment level (CAL) )
Time frame: average 1 year
Measured in mm from CEJ
Probing Pocket Depth (PPD)
Time frame: average 1 year
Measured in mm from free Gingival margin.
Interproximal Alveolar Bone level(From CEJ)
Time frame: average 1 year
Measured from CEJ
Pattern of bone Loss.
Time frame: average 1 year
Measured from CEJ
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- 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.
Ashish Kumar, BDS principal investigator
Post Graduate Institute of Dental Sciences ,Rohtak
1 site in 1 country: see every site and its status.
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.