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CTRI Number  CTRI/2022/06/043581 [Registered on: 29/06/2022] Trial Registered Prospectively
Last Modified On: 28/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   estimation of pulp stones and its relationship with local factors and systemic diseases-a cone beam computed tomography study 
Scientific Title of Study   Assessment of pulp stones and its correlation with local factors and systemic diseases-A cone beam computed tomographic study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPeetha Krupavathi 
Designation  post graduate student 
Affiliation  sibar institute of dental sciences 
Address  Room no 01,Department of Oral medicine and radiology, Sibar instuite of dental sciences, Takellapadu,guntur Andhra Pradesh

Guntur
ANDHRA PRADESH
522509
India 
Phone  9154009353  
Fax    
Email  krupavathi1912@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Y Samatha 
Designation  professor and HOD 
Affiliation  sibar institute of dental sciences 
Address  Room no 01,Department of Oral medicine and radiology, Sibar instuite of dental sciences, Takellapadu,guntur Andhra Pradesh

Guntur
ANDHRA PRADESH
522509
India 
Phone  9391307194  
Fax    
Email  dra.samatha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrPeetha Krupavathi 
Designation  post graduate student 
Affiliation  sibar institute of dental sciences 
Address  Room no 01,Department of Oral medicine and radiology, Sibar instuite of dental sciences, Takellapadu,guntur Andhra Pradesh


ANDHRA PRADESH
522509
India 
Phone  9154009353  
Fax    
Email  krupavathi1912@gmail.com  
 
Source of Monetary or Material Support  
sibar institute of dental sciences 
 
Primary Sponsor  
Name  DrPeetha Krupavathi 
Address  Room no 01,Department of Oral medicine and radiology,Sibar institute of dental sciences,Takellapadu,Guntur,Andhra pradesh,522509 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr peetha krupavathi  sibar institute of dental sciences  department of oral medicine and radiology sibar institute of dental sciences takellapadu guntur ANDHRA PRADESH
Guntur
ANDHRA PRADESH 
9154009353

krupavathi1912@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SIBAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K043||Abnormal hard tissue formation inpulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects >14 years of age will be included in this study.
Subjects who are willing to give their consent for the study
 
 
ExclusionCriteria 
Details  Systemic diseases impacting calcium levels in the body.
Patients under long term calcium supplements
Retained deciduous teeth
Tooth with developmental anomalies.
Tooth with resorbed roots.
Fractured teeth.
Teeth with metal crowns.
Teeth with previous root canal treatment.
Unerupted teeth and third molars
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
assessment of site,shape,number,size of pulp stones   baseline 
 
Secondary Outcome  
Outcome  TimePoints 
assessment of correlation between pulp stones and systemic diseases,local factors  baseline 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TITLE: ASSESSMENT OF PULP STONES AND ITS CORRELATION WITH LOCAL FACTORS AND SYSTEMIC DISEASES- A CONE BEAM COMPUTED TOMOGRAPHIC STUDY.

 

PRINCIPAL INVESTIGATOR: PEETHA KRUPAVATHI

DEPARTMENT: ORAL MEDICINE AND RADIOLOGY

                                 SIBAR INSTITUTE OF DENTAL SCIENCES, GUNTUR

INTRODUCTION:

                   Pulp stones are calcified bodies in the dental pulp of the teeth, which may occur in health or disease, deciduous or permanent, one or multiple teeth, and in unerupted or impacted teeth1. They are classified based on their location as free, adherent, and embedded pulp stones2.

                  Bernick and Nedelman found decrease in the size of pulp chamber due to the deposition of secondary dentin, with increasing age and progressive deposition of calcified masses originating in the root. Although the exact cause for the formation of pulp stones is not clear, multiple factors such as aging, periodontal disease, various systemic diseases, genetic predisposition, bacterial infection, deep caries, restorations and orthodontic tooth movement can lead to pulp stones3.Carious lesion or irritation to the pulp stimulates inflammatory changes within pulp, leading to reparative dentin formation and increased calcification3. The presence of pulp stones and their significance with systemic diseases is still inconclusive in literature.

                   CBCT offers a sensitive diagnostic system to detect pulp stones as compared to 2-dimensional radiographic techniques4. Pulp stones appear radiographically as round or ovoid opacities within the pulp5.The prevalence of pulp stones in teeth, based on radiographic examination, has been reported to be around 20–25%.

 

 

 

 

REVIEW OF LITERATURE:

 1.Chen G et al (2022): conducted a study to assess the pulp stones in subjects with periodontal diseases using digital panoramic and periapical radiographs. They retrospectively reviewed radiological records of 465 subjects [(12,407 teeth) (271 male,194 female)] who received full mouth periodontal treatment for chronic generalized periodontitis. They concluded that pulp stones were more often seen in maxillary molar teeth and in subjects greater than 40 years of age with periodontal conditions.

 2.Gowthami Jawahar et al (2021): conducted a study to evaluate the radiological and histological features of pulp stones with clinical parameters such as age, gender, tooth involved, dental caries, trauma and also histological correlation with occurrence of pulp stones in systemic hypertension and hyperlipidemia. A total of 70 subjects (9-65 years of age) with periapical radiographs were analyzed. The results showed that there is significant association between age, trauma and caries with the presence of pulp stones and also concluded that there is a positive correlation between pulp stones and hypertension & hyperlipidemia.

 3.Kumar Chandan Srivastava et al (2020): conducted a retrospective, observational study to assess the prevalence of pulp stones with cardiovascular disease and diabetes mellitus. In this study, 3 groups were involved. Group 1, including cardiovascular diseases, group 2 including diabetes mellitus and group 3, involving the healthy control groups. A total of 229 CBCT scans (4807 teeth) were screened for pulp stones. They concluded that the prevalence of pulp stones is higher in subjects with cardiovascular diseases and older age groups (>50 years).

4.Guzide Pelin Sezgin et al (2020): conducted a retrospective study to assess the presence of pulp stones through CBCT images and to correlate their prevalence with age, sex, dental arch and side, tooth type, restoration type and depth. In this study, CBCT images were obtained from 673 subjects who had subsequently underwent diagnostic CBCT imaging. Total 11,494 teeth were examined. They concluded that the maxillary dental arches, molar teeth, medium depth restorations and individuals of age 30-39 years have higher risk of pulp stone formation.

5.Ertas ET et al (2017): conducted a retrospective clinical follow up study to assess the incidence of pulp stone formation during orthodontic treatment. A total of 545 subjects of 12-22 years of age who had undergone non extraction orthodontic treatment was selected. Pre and post treatment panoramic radiographs were collected,8442 teeth from pretreatment radiographs and 8410 teeth from post treatment panoramic radiographs were evaluated. They concluded that orthodontic treatment triggers the formation of dental pulp stones.

6.Nayak M et al (2010): conducted a prospective study to determine the radiographic association between pulp stones and systemic disorders. A total of 1432 teeth from 150 subjects of 20-55 years of age with various systemic disorders were selected. The 150 subjects were equally divided into 5 groups. Group 1, subjects with h/o cardiovascular disorders, group 2, type 2 diabetes mellitus, group 3, autoimmune disorders, group 4, dental wear defects, group 5, control group. Subjects periapical radiograph with conventional film and radio visiograph (RVG) from full mouth series were recorded. Presence or absence of pulp stones was recorded. The results showed that occurrence of pulp stones was significantly higher in subjects with cardiovascular disorders.

AIM:

To assess the presence of pulp stones and its correlation with local factors and systemic diseases.

OBJECTIVES:

1. To assess the presence of pulp stones in subjects with systemic diseases. 

2. To assess the presence of pulp stones in teeth with local factors.

3. To assess the presence of pulp stones in subjects without local factors and systemic diseases.

4. To compare the presence of pulp stones in subjects with and without local factors/ systemic diseases.

MATERIALS AND METHODS:

Source of Data:  CBCT scans of subjects taken in OMR department

Study Design: Prospective Study

Study Period: June 2022 to November 2023

INCLUSION CRITERIA:

1.Subjects >14 years of age will be included in this study.

2.Subjects who are willing to give their consent for the study.

EXCLUSION CRITERIA:

1.Systemic diseases impacting calcium levels in the body.

2.Patients under long term calcium supplements

3.Retained deciduous teeth

4.Tooth with developmental anomalies.

5.Tooth with resorbed roots.

6.Fractured teeth.

7.Teeth with metal crowns.

8. Teeth with previous root canal treatment.

9. Unerupted teeth and third molars.

Procedure:

               A structured case history will be taken of the study subjects prior to CBCT scan. All the subjects will be explained about the importance of study and a written consent form will be obtained prior to the participation of the study. All the patients will be subjected to random blood sugar level estimation. CBCT scans of subjects will be taken using Carestream CS 9300-3D machine and images will be stored in DICOM format and will be evaluated with CS Imaging software.

                Radiographic CBCT scans of study subjects will be interpreted by two maxillofacial radiologists independently to avoid inter observer variations. Individual teeth in the CBCT scan will be assessed for the presence of pulp stones and also its site, size, number and type will be recorded. Local factors such as attrition, dental caries, restoration and bone loss will also be noted.

Based on the history and CBCT scan, all the subjects will be categorized into 3 groups:

GROUP 1-Teeth (CBCT scan) of subjects with systemic diseases.

                a) Subjects with history of cardiovascular disorders such as angina pectoris,     myocardial infarction, heart surgery, hypertension, congestive heart failure, cerebrovascular accident, hypercholesterolemia or arrhythmia.

                 b)  Subjects with a history of diabetes mellitus, diagnosed according to WHO criteria – RBS ≥200 mg/dl (or) FBS ≥ 126 mg/dl (or) glycosylated Hb (HbA1 C) > 7% will be selected.

GROUP 2- Teeth (CBCT scan) of subjects with local factors such as attrition, dental caries, restoration and bone loss.

GROUP 3 – Control groups (without any local or systemic factors).

CATEGORIZATION OF TYPES OF PULP STONES (2):

Free pulp stone: lies freely and it is surrounded by pulp.

Embedded pulp stone: It is fully embedded in dentin and most commonly found in the apical portion of the root.

Adherent pulp stone: attached to the wall of pulp space but not fully enclosed by dentin.              

 

POTENTIAL RISKS: There are no significant risks associated with the study.

POTENTIAL BENEFITS:

1.As dental radiographs are taken very frequently; presence of pulp stones could be a diagnostic factor for systemic diseases.

2. Knowledge of pulp stones distribution can aid dentists in clinical procedures like root canal treatment.

STATISTICAL ANALYSIS:

            The analysis will be performed using SPSS version 20.0. The frequency of distribution of pulp stones in all the three groups will be calculated by descriptive statistics. Pearson’s chi-square test will be used to investigate the significant correlation between the incidence of pulp stones with study parameters. ANOVA test will be performed to compare the size of pulp stones in between the groups.                

REFERENCES:

1. Gin Chen , Liang-Gie Huang , Pei-Cheng Yeh . Detecting calcified pulp stones in patients with periodontal diseases using digital panoramic and periapical radiographies. J. Dent. Sci.2022 ISSN 1991-7902

2.Gowthami Jawahar et al. Clinicopathological Correlation of Pulp Stones and Its Association with Hypertension and Hyperlipidemia: An Hospital-based Prevalence Study. J Pharm Bioallied Sci. 2021;13(2: S1274.

3.Kumar Chandan Srivastava et al. Assessing the Prevalence and Association of Pulp Stones with Cardiovascular Diseases and Diabetes Mellitus in the Saudi Arabian Population-A CBCT Based Study. Int J Environ Res Public Health. 2020;17(24):9293.

4. Sezgin GP, Sönmez Kaplan S, Kaplan T. Evaluation of the relation between the pulp stones and direct restorations using cone beam computed tomography in a Turkish subpopulation. Restor Dent Endod. 2021;46(3): e34.

5. Ertas E T, Veli I, Akin M, Ertas H, Atici M Y. Dental pulp stone formation during orthodontic treatment: A retrospective clinical follow-up study. Niger J Clin Pract 2017; 20:42.

6.Nayak M, Kumar J, Prasad LK. A radiographic correlation between systemic disorders and pulp stones. IJDR. 2010;21(3):369.

 
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