NCT04702867

Association Between Periodontal Bone Loss and Maxillary Sinus Changes.

Status unknown Last updated 11 January 2021

What this trial tests

trial in Maxillary Sinus Disease in 450 participants. Status unknown.

Timeline

1 February 2021

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Postgraduate Institute of Dental Sciences Rohtak
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	450
Start date	1 February 2021
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across India

Conditions studied

• Maxillary Sinus Disease — all drugs for Maxillary Sinus Disease →
• Periodontal Bone Loss — all drugs for Periodontal Bone Loss →

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Who can join

18 and older, any sex, with Maxillary Sinus Disease or Periodontal Bone Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.