Periodontitis, ChronicNCT06426069
Assessment of Masticatory Performance in Periodontitis
An observational study of Periodontitis, Chronic and Chewing Problem, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Chronic, Chewing Problem, Inflammation
- What is being tested?
- Masticatory efficiency assessment
- How many people
- 555 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2024to Jan 2025
- Phase
- Observational
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 555 patients will be recruited from the out patient department of periodontics, PGIDS, Rohtak based on the inclusion and exclusion criteria. The study design will be explained to eligible candidates and all study participants will be required to provide informed consent. Subjects will be grouped based on stage of periodontitis and a healthy control group.
Who may be able to join
- Adult patients with age group 30-50 years diagnosed with generalized periodontitis
- Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
Who cannot join
- Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria)
- Smoking or substance abuse
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Masticatory Performance in Various Stages of Periodontitis
The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium.
Read the detailed description
Periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. Loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. Thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. Even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. Since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations.
This clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice.
- Conditions
- Periodontitis, Chronic, Chewing Problem, Inflammation
- Being tested
- Masticatory efficiency assessment
- Medical subject headings
- Chronic Periodontitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masticatory efficiency assessmentOther
Masticatory efficiency will be assessed for each group.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy | Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. Receives: Other: Masticatory efficiency assessment | |
| Stage I Periodontitis | Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. Receives: Other: Masticatory efficiency assessment | |
| Stage II Periodontitis | Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. Receives: Other: Masticatory efficiency assessment | |
| Stage III Periodontitis | Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. Receives: Other: Masticatory efficiency assessment | |
| Stage IV Periodontitis | Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. Receives: Other: Masticatory efficiency assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective masticatory performance
Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software.
Measured: Baseline
Secondary outcomes (1)
Subjective masticatory performance
Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, ChronicStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 555 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janvi Janvi, BDS, Principal investigator, PGIDS Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426069
- Sponsor's protocol ID
- JANVIPERIO2024
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Masticatory Performance in Various Stages of Periodontitis
- ClinicalTrials.gov ID
- NCT06426069
- Acronym / sponsor ID
- JANVIPERIO2024
- Conditions
- Periodontitis, Chronic, Chewing Problem, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 555 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 23 May 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.
The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.This clinical trial aims to assess the status of masticatory performance among patients with stage I, stage II, stage III and stage IV periodontitis, along with those with healthy periodontium.
Detailed description
Periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. The loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. Loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. Thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. Even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. Since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations.
This clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | – | Other: Masticatory efficiency assessmentComplete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. |
| Stage I Periodontitis | – | Other: Masticatory efficiency assessmentComplete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. |
| Stage II Periodontitis | – | Other: Masticatory efficiency assessmentComplete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. |
| Stage III Periodontitis | – | Other: Masticatory efficiency assessmentComplete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. |
| Stage IV Periodontitis | – | Other: Masticatory efficiency assessmentComplete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BOP), plaque index (PI) and gingival index (GI) and mobility. Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum. Subjective masticatory performance will be calculated using The Quality of Masticatory Function Questionnaire. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 555 patients will be recruited from the out patient department of periodontics, PGIDS, Rohtak based on the inclusion and exclusion criteria. The study design will be explained to eligible candidates and all study participants will be required to provide informed consent. Subjects will be grouped based on stage of periodontitis and a healthy control group.
Key inclusion criteria (2 listed)
- Adult patients with age group 30-50 years diagnosed with generalized periodontitis
- Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.
Key exclusion criteria (5 listed)
- Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
- Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
- Grade C periodontitis (evaluated indirectly by radiographic bone loss/age criteria)
- Smoking or substance abuse
- Pregnant and lactating women
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 |
|---|---|---|
| Masticatory efficiency assessmentMasticatory efficiency will be assessed for each group. | Other | Periodontally Healthy, Stage I Periodontitis, Stage II Periodontitis, Stage III Periodontitis, Stage IV Periodontitis |
Primary outcome
Objective masticatory performance
Time frame: Baseline
Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software.
1 secondary outcome
Subjective masticatory performance
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
Related trials for Periodontitis, Chronic
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
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.
Janvi Janvi, BDS principal investigator
PGIDS 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 Periodontitis, Chronic and Chewing Problem, 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 2 inclusion and 5 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 23 May 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 Rajinder K Sharma, MDS (09416358222, rksharmamds@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective masticatory performance (time frame: Baseline). 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 23 May 2024.