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Maxillary Sinus DiseaseNCT04702867

Association Between Periodontal Bone Loss and Maxillary Sinus Changes.

An observational study of Maxillary Sinus Disease and Periodontal Bone Loss, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

AIM AND OBJECTIVES: AIM To determine the association between periodontal bone loss and maxillary sinus changes through cone beam computed tomography. OBJECTIVES Primary objectives- 1. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
450 participants
Where
1 siteIndia
Study dates
1 Feb 2021to 30 Jun 2021
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: CBCT volumes of patients who have undergone CBCT examination between May 2019 and December 2020 for various dental purposes will be evaluated and the volumes fulfilling the inclusion criteria will be included in the study. The subjects will be divided into 2 groups- Periodontal bone loss group and Healthy group

Who may be able to join

  • 1. Good quality images with visualization of maxillary sinus and maxillary posterior teeth of at least one side.

Who cannot join

  • 1. Signs of endodontic pathology like periapical radiolucency, root canal fillings etc.
  • 2. Presence of metal artifacts interfering with the view of the maxilla. 3. Presence of trauma or pathologies such as tumours, cysts or malignancies that obscure the view of the region of interest.

Trial locations and contacts

1 site in 1 country.

India1 site
  • Post Graduate Institute of Dental Sciences

    Rohtak, Haryana, 124001

Other trials in India

About this study

Official title: Association Between Periodontal Bone Loss and Maxillary Sinus Changes Determined Using Cone Beam Computed Tomography - A Retrospective Study

AIM AND OBJECTIVES:

AIM To determine the association between periodontal bone loss and maxillary sinus changes through cone beam computed tomography.

Read more

OBJECTIVES Primary objectives- 1. To compare the presence of maxillary sinus changes in patients with radiographic evidence of periodontal bone loss with healthy controls.

Secondary objectives-

  1. To determine the correlation between severity of periodontal bone loss with the changes in maxillary sinus.
  2. To compare the mean maxillary sinus mucosal thickening in patients with radiographic evidence of periodontal disease with healthy controls.

MATERIALS AND METHODOLOGY:

STUDY DESIGN A retrospective study will be conducted in the department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.

STUDY SETTING Hospital based study - CBCT volumes which are available in the archives of Oral Medicine and Radiology department will be evaluated.

STUDY PERIOD This study will be completed in 6 months. STUDY SUBJECTS CBCT volumes of patients who have undergone CBCT examination between May 2019 and December 2020 for various dental purposes will be evaluated and the volumes fulfilling the inclusion criteria will be included in the study. The subjects will be divided into 2 groups- Periodontal disease group and Healthy group, INCLUSION CRITERIA

  1. Good quality images with visualization of maxillary sinus and maxillary posterior teeth of at least one side.

EXCLUSION CRITERIA

  1. Signs of endodontic pathology like periapical radiolucency, root canal fillings etc.
  2. Presence of metal artifacts interfering with the view of the maxilla.
  3. Presence of trauma or pathologies such as tumours, cysts or malignancies that obscure the view of the region of interest.

SAMPLE SIZE A minimum sample size of 71 maxillary scans in each group has been calculated to expect a difference of 26.84% in the prevalence of the 2 groups as ascertained from a pilot study, at a significance level of 0.05 and a power of 90%.

Since group one will further be divided into 3 classes, a sample size of 225 in each group shall be taken.

METHODOLOGY

  • CBCT volumes of patients who have undergone CBCT for various dental purposes between May 2019 to December 2020 available in the archives of Department of Oral medicine and radiology will be evaluated.
  • These scans will be screened for radiographic evidence of periodontal disease i.e. horizontal or vertical bone loss and bone loss at the furcation.
  • Further, the periodontal bone loss scans i.e. 225 will be divided into 3 groups of 75 each: mild (<25%), moderate (25-50%) and severe (>50%) according to the amount of bone loss.
  • The group with no bone loss will be taken as the control group i.e. 225.
  • Maxillary sinuses will be evaluated according to the following criteria; score range from 0 to 6 ; 0 - no mucosal changes.,1 - area without cortical bone and with soft tissue density, thickness >3 mm, parallel to sinus bone wall,2- sinus polyp, 3-antral pseudo cyst, 4- non-specific opacification,5- periostitis,6- antrolith.

DATA MANAGEMENT AND STATISTICAL ANALYSIS Data will be tabulated in Microsoft Excel sheet. The results will be expressed as the frequency (%) of maxillary and Mean + Standard deviation (SD) for maxillary sinus mucosal thickening. Normality of data will be assessed and Chi-square or student T test shall be used for non-parametric and parametric data respectively. All analysis will be performed by SPSS software version 21. A p value less than 0.05 will be considered significant for all outcomes.

Read the detailed description

TITLE: "Association between Periodontal bone loss and Maxillary sinus changes determined using Cone beam computed tomography-A retrospective study." RATIONALE: Odontogenic maxillary sinusitis (OMS) is a type of inflammation of the maxillary sinus mucosa which results from dental infections such as chronic apical periodontitis, periodontal infections, tooth extractions and sinus lift procedures. The first and second molars are close to the floor of the maxillary sinus followed by the premolar teeth and occasionally canine.5In the otorhinolaryngological literature, the incidence of odontogenic sinusitis has been underreported in the past, with 10-12% of OMS cases attributed to odontogenic infections. However, recent studies are suggestive of a much higher incidence i.e. 40% of all cases of CMS.

Periodontal disease has been attributed as one of the causes of odontogenic maxillary sinusitis by various studies. The studies done so far offer some limitations such as lack of a control group, lack of corelation with disease severity, not taking focal sinus thickening adjacent to the infected tooth into consideration, small sample sizes and lack of clinical correlation.

Thus, this study aims to determine the association between periodontal disease and maxillary sinusitis through cone beam computed tomography in an Indian subpopulation attempting to overcome the limitations of the previous studies.

RESEARCH QUESTION P: Population (Patients with radiographic evidence of periodontal disease in their CBCT images) I: Intervention (none) C: Control(Patients with no evidence of periodontal disease in their CBCT images) O: Outcome (Radiographic signs of maxillary sinus changes) T: Time Frame (6 months) S: Study Design (Retrospective study) Setting in Haryana , India Is periodontal bone loss a risk factor for development of maxillary sinus changes?

AIM AND OBJECTIVES:

AIM To determine the association between periodontal bone loss and maxillary sinus changes through cone beam computed tomography.

OBJECTIVES Primary objectives- 1. To compare the presence of maxillary sinus changes in patients with radiographic evidence of periodontal bone loss with healthy controls.

Secondary objectives-

  1. To determine the correlation between severity of periodontal bone loss with the changes in maxillary sinus.
  2. To compare the mean maxillary sinus mucosal thickening in patients with radiographic evidence of periodontal disease with healthy controls.

MATERIALS AND METHODOLOGY:

STUDY DESIGN A retrospective study will be conducted in the department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.

STUDY SETTING Hospital based study - CBCT volumes which are available in the archives of Oral Medicine and Radiology department will be evaluated.

STUDY PERIOD This study will be completed in 6 months. STUDY SUBJECTS CBCT volumes of patients who have undergone CBCT examination between May 2019 and December 2020 for various dental purposes will be evaluated and the volumes fulfilling the inclusion criteria will be included in the study. The subjects will be divided into 2 groups- Periodontal disease group and Healthy group, INCLUSION CRITERIA

  1. Good quality images with visualization of maxillary sinus and maxillary posterior teeth of at least one side.

EXCLUSION CRITERIA

  1. Signs of endodontic pathology like periapical radiolucency, root canal fillings etc.
  2. Presence of metal artifacts interfering with the view of the maxilla.
  3. Presence of trauma or pathologies such as tumours, cysts or malignancies that obscure the view of the region of interest.

SAMPLE SIZE A minimum sample size of 71 maxillary scans in each group has been calculated to expect a difference of 26.84% in the prevalence of the 2 groups as ascertained from a pilot study, at a significance level of 0.05 and a power of 90%.

Since group one will further be divided into 3 classes, a sample size of 225 in each group shall be taken.

METHODOLOGY

  • CBCT volumes of patients who have undergone CBCT for various dental purposes between May 2019 to December 2020 available in the archives of Department of Oral medicine and radiology will be evaluated.
  • These scans will be screened for radiographic evidence of periodontal disease i.e. horizontal or vertical bone loss and bone loss at the furcation.
  • Further, the periodontal bone loss scans i.e. 225 will be divided into 3 groups of 75 each: mild (<25%), moderate (25-50%) and severe (>50%) according to the amount of bone loss.
  • The group with no bone loss will be taken as the control group i.e. 225.
  • Maxillary sinuses will be evaluated according to the following criteria; score range from 0 to 6 ; 0 - no mucosal changes.,1 - area without cortical bone and with soft tissue density, thickness >3 mm, parallel to sinus bone wall,2- sinus polyp, 3-antral pseudo cyst, 4- non-specific opacification,5- periostitis,6- antrolith.

DATA MANAGEMENT AND STATISTICAL ANALYSIS Data will be tabulated in Microsoft Excel sheet. The results will be expressed as the frequency (%) of maxillary and Mean + Standard deviation (SD) for maxillary sinus mucosal thickening. Normality of data will be assessed and Chi-square or student T test shall be used for non-parametric and parametric data respectively. All analysis will be performed by SPSS software version 21. A p value less than 0.05 will be considered significant for all outcomes.

ETHICAL CONSIDERATION Ethical clearance will be obtained from the Bio-medical \& Health Research Ethics Committee (BHRC), PGIDS Rohtak to conduct the study. Patient confidentiality would be maintained by not disclosing their details

Medical subject headings
Alveolar Bone Loss

What participants receive

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

Study groups in NCT04702867
Study groupRoleWhat they receive
Periodontal bone loss groupThe cases with level of alveolar crest more than 2 mm from the CEJ as measured using CBCT scan on mesial and distal sides of all premolar and molar teeth.
Healthy groupThe cases with level of alveolar crest equal to or less than 2 mm from the CEJ as measured using CBCT scan on mesial and distal sides of all premolar and molar teeth.

What is being measured

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

  1. Changes in the maxillary sinus.

    • Maxillary sinuses will be evaluated according to the following criteria; score range from 0 to 6
    • 0 - no mucosal changes.
    • 1 - area without cortical bone and with soft tissue density, thickness >3 mm, parallel to sinus bone wall
    • 2- sinus polyp
    • 3-antral pseudo cyst
    • 4- non-specific opacification
    • 5- periostitis
    • 6- antrolith.
    • Maxillary sinuses will be evaluated according to the following criteria; score range from 0 to 6
    • 0 - no mucosal changes.
    • 1 - area without cortical bone and with soft tissue density, thickness >3 mm, parallel to sinus bone wall
    • 2- sinus polyp
    • 3-antral pseudo cyst
    • 4- non-specific opacification
    • 5- periostitis
    • 6- antrolith. USING CBCT VIEWER PROGRAM

    Measured: 6 months

Secondary outcomes (1)
  1. Thickness of mucosal lining of the maxillary sinus.

    Measured using in built linear measurement tools in CBCT viewer program .

    Measured: 6 months

Timeline

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

  1. First posted11 Jan 2021
  2. Study start1 Feb 2021 (estimated)
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2021 (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
Other
Time perspective
Retrospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04702867
Sponsor's protocol ID
Harshapopli27
Status last verified
Jan 2021
First submitted
7 Jan 2021
Last updated
11 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Maxillary Sinus Disease and Periodontal Bone Loss, 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 1 inclusion and 2 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 11 Jan 2021. 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 Sanjay Tewari, MDS (2283876 ext. 0126, principalpgidsrohtak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the maxillary sinus. (time frame: 6 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 11 Jan 2021.

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