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CTRI Number  CTRI/2018/01/011339 [Registered on: 15/01/2018] Trial Registered Retrospectively
Last Modified On: 13/01/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   This is an Observational Type of Study for evaluation of Gingival and Gingival Zenith Angles in Maxillary Anterior Teeth. 
Scientific Title of Study   Evaluation of Gingival and Gingival Zenith Angles in Maxillary Anterior Teeth. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhay Kolte 
Designation  Professor and Head of Department 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  Dept of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax  09011071467  
Email  drabhaypkolte@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhay Kolte 
Designation  Professor and Head of Department 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  Dept of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax  09011071467  
Email  drabhaypkolte@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay Kolte 
Designation  Professor and Head of Department 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  Dept of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax  09011071467  
Email  drabhaypkolte@gmail.com  
 
Source of Monetary or Material Support  
Self(Dr Abhay Kolte Professor and Head of Department VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur) 
 
Primary Sponsor  
Name  Dr Abhay Kolte 
Address  Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur 
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 Abhay Kolte  Dept of Periodontics and Implantology  Room no 104 Dept of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road
Nagpur
MAHARASHTRA 		 9011071467

drabhaypkolte@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPM Dental College and Research Centre Ethics Committee.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontally and systemically healthy patients. 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients who are willing to participate and sign the informed consent for this clinical trial.
2.Healthy gingiva with a plaque and gingival index score of 0–1 (Loe & Silness 1963)
3.Patients with fully erupted well-aligned maxillary central incisors lateral incisors and canines.
 
 
ExclusionCriteria 
Details  1.Patients diagnosed with destructive periodontal disease.
2.A history of surgery in the anterior maxillary area or open contact or crowding observed visually without aid.
3.Pregnancy or a history of taking medications known to increase the risk of gingival hyperplasia.
4.Evidence of caries either on the inter proximal surface or at cemento-enamel junction.
5.Presence of an artificial crown proximal cervical restorations or abrasions on the central incisors lateral incisors and canines.
6.Evidence of incomplete passive eruption.
7.Orthodontically treated areas. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the gingival angle in males and females of different age groups in maxillary central incisor lateral incisor and canine on both right and left side.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To find the gingival zenith angle  6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/03/2017 
Date of Study Completion (India) 12/09/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study was conducted to evaluate  gingival and gingival zenith angles in maxillary anterior teeth.

 A total of 120 subjects with age range of 20-60 years including both male and female visiting the Department of Periodontics at VSPM Dental College and Research Centre Nagpur were recruited. Study was divided into 2 groups Group I  Comprised of periodontally and systemically healthy patients.  30 males and 30 females within an age range of 21-40 years. Group II  Comprised of periodontally and systemically healthy patients. 30 males and 30 females within an age range of 41-60 years.

A brief description of entire procedure was given to every patient before starting procedure. Written informed consent was taken from the patients who wished to enroll in the study.

For all subjects following periodontal parameters were recorded:

1.      Plaque index (Silness and Loe 1964)

2.      Gingival index (Loe and Silness 1963)

After clinical examination, alginate impression of the maxillary and mandibular jaws were taken in stock metal tray and poured in dental stone, according to the manufacturer’s instructions to obtain the study model of the patient. On the study model impression following parameters were measured

1.      Gingival angle

Gingival zenith angle

Results- The results of the present study showed that difference between gingival angle and gingival zenith angle in group I and group II as well as for males and females were highly significant.The mean values of gingival angle of group I for central incisor , lateral incisor and canine were 93.17 ± 4.37, 91.09 ± 4.59 and 88.92 ± 4.85 respectively and for group II were 91.73 ± 4.29, 89.90 ± 4.24 and 88.16 ± 4.24 respectively for males. The mean values of gingival angle of group I for central incisor , lateral incisor and canine were 85.06 ± 5.15, 83.15 ± 4.96, 81.26 ± 4.96 respectively and for group II were 84.42 ± 5.74, 82.58 ± 5.42 and 80.77 ± 5.28 respectively for females.The mean values of gingival zenith angle of group I and group II were 155.53 ± 3.34, 155.89 ± 2.54 for 1st quadrant and 156.41 ± 3.01, 156.46 ± 2.65 respectively for males. The mean values of gingival zenith angle of group I and group II were 147.76 ± 2.68, 146.93 ± 3.08 for 1st quadrant and 148.64 ± 2.91,147.87 ± 2.98 respectively for females.

 

 
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