Association Between Periodontal Bone Loss and Maxillary Sinus Changes.

NCT04702867 | Unknown

• 1 other identifier: Harshapopli27
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

• 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.

Conditions

Maxillary Sinus Disease; Periodontal Bone Loss

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (1)

• Thickness of mucosal lining of the maxillary sinus.

  6 months

Study Arms (2)

Periodontal bone loss group

The 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 group

The 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• \- 1. Signs of endodontic pathology like periapical radiolucency, root canal fillings etc.
• \. 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Sanjay Tewari, MDS

CONTACT

2283876; principalpgidsrohtak@gmail.com

Ambika Gupta, MDS

CONTACT

9315903300; drambika79@rediffmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: February 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

IN (1)