| CTRI Number |
CTRI/2020/03/024282 [Registered on: 26/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to evaluate and correlate the papillary proportion in periodontally healthy males and females. |
|
Scientific Title of Study
|
Evaluation and Correlation of mesial and distal papillary proportion and crestal papillary proportion in periodontally healthy patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
VSPM Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur 440019 |
| Address |
104, Department of Periodontics and Implantology,
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
VSPM Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur 440019 |
| Address |
104, Department of Periodontics and Implantology,
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Professor and Head |
| Affiliation |
VSPM Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur 440019 |
| Address |
104, Department of Periodontics and Implantology,
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur.
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Implantology,
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajashri Kolte |
VSPM Dental College and Research Centre, Digdoh Hills Hingna road Nagpur: 440019 Maharashtra India |
Department Of
Periodontics and
Implantology,
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9011071468
drrajashrikolte@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontally healthy Males and Females within the age range of 20 to 40 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
Periodontally healthy males and females within the age range of 20 to 40 years. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to participate and sign the informed consent for this clinical trial.
2. Males and females between the age range of 20-40 years.
3. Healthy gingiva as assessed with a Plaque Index (Silness & Loe 1964) and Gingival Index (Loe & Silness 1963) between the score of 0–1.
4. Patients with fully erupted well-aligned maxillary Central Incisors, Lateral Incisors and Canines without any orthodontic anomaly.
5. Patients with non-restored maxillary anterior teeth, no loss of interdental papillae.
6. Patients with no signs of anterior spacing or crowding.
7. Patients with probing pocket depth (PPD) ≤ 2 mm.
|
|
| ExclusionCriteria |
| Details |
1. Patients exhibiting any signs of periodontal disease.
2. A history of surgery in the anterior maxillary area.
3. Pregnancy or a history of taking medications known to increase the risk of gingival hyperplasia.
4. Evidence of caries either on the interproximal 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. Maligned or orthodontically treated teeth.
8. Crowding, spacing, gingival recession, attrision with maxillary anterior teeth.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and correlate the mesial and distal papillary proportion and crestal papillary proportion in periodontally healthy males and females. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the mesial and distal papillary proportion in periodontally healthy males and females.
To evaluate the crestal papillary proportion in periodontally healthy males and females.
To correlate the mesial and distal papillary proportion and crestal papillary proportion in periodontally healthy patients. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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 will be conducted to assess 840 interdental sites in maxillary anterior region (left canine to right canine). Papillary proportion will be evaluated on study models, Crestal Papillary Proportion will be evaluated using radiovisiograph (RVG). A total of 120 subjects within the age range of 20-40 years, including both males and females visiting the Department of Periodontics and Implantology, at VSPM Dental College and Research Centre, Nagpur will be recruited. Study population will be divided into 2 groups: Group I – 60 periodontally healthy males within the age range of 20-40 years. Group II - 60 periodontally healthy females within the age range of 20-40 years. Written informed consent will be taken from the patients who wish to enroll in the study. Alginate impressions of the maxillary and mandibular arches will be taken in stock metal tray and poured in dental stone, according to the manufacturer’s instructions to obtain the study model of the patient. Frontal digital photographs will be taken from standard distance of 3 feet with cheek retractor. RVG of maxillary anterior teeth (from canine to canine region) taken after radiopaque dye application at the tip of interdental papilla. The Mesial and distal Gingival Zenith position, Papilla Proportion, Crestal papilla proportion (CPP) will be evaluated. Gingival Zenith position (GZP): The highest point of the free gingival margin of Central Incisors, Lateral Incisors, Canine will be marked. Papilla Proportion = papilla height/ crown length × 100% 1) Mesial papillary proportion (MPP) = mesial papilla height/ crown length × 100% 2) Distal papillary proportion (DPP) = distal papilla height/ crown length × 100% Crestal papilla proportion (CPP) = RBL / crown length × 100% 3) Mesial crestal papillary proportion (MCrPP) = mesial RBL / crown length × 100% 4) Distal crestal papillary proportion (DCrPP) = distal RBL/ crown length × 100% |