| CTRI Number |
CTRI/2020/11/029408 [Registered on: 26/11/2020] Trial Registered Prospectively |
| Last Modified On: |
25/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of mesiodistal and faciopalatal dimensions of interproximal area with the presence of interdental papillae and thickness of gingiva in faciopalatal dimension in maxillary anterior teeth. |
|
Scientific Title of Study
|
Evaluation and correlation of mesiodistal and faciopalatal horizontal and vertical dimensions of interproximal area with the presence of interdental papillae and gingival biotype 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 Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur |
| Address |
104, Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
104, Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
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, Nagpur |
| Address |
104, Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
104, Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur |
| Address |
104, Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
104, Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104, Department of Periodontics and Implantology
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
|
|
|
Primary Sponsor
|
| Name |
Dr Rajashri Kolte |
| Address |
104, Department of Periodontics and Implantology
VSPM Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019 |
| Type of Sponsor |
Other [Dr Rajashri Kolte] |
|
|
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, Nagpur |
104, Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
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 |
Absence of periodontal disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
. Patients who are willing to participate and sign the informed consent for this clinical trial.
2. Males and females between the age group of 20-40 years.
3. Periodontally healthy patients 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 orthodontic anomaly.
|
|
| ExclusionCriteria |
| Details |
. Artificial crowns, fillings, attrition on anterior teeth.
2. Congenitally missing anterior tooth or teeth.
3. Pregnancy or a history of taking medications known to increase the risk of gingival hyperplasia.
4. Patients diagnosed with destructive periodontal disease or hypertrophy.
5. Patients with a history of any periodontal treatment in the past six months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and correlate the mesiodistal and faciopalatal horizontal and vertical dimensions of interproximal area with the presence of interdental papilla and gingival biotype in maxillary anterior teeth in periodontally healthy males and females. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the mesiodistal and faciopalatal horizontal and vertical dimensions of interproximal area, presence or absence of interdental papillae, the gingival biotype, in maxillary anterior teeth in males and females.
2.To correlate the mesiodistal and faciopalatal horizontal and vertical dimensions of interproximal area with the presence of interdental papilla and gingival biotype in maxillary anterior teeth in males and females.
|
Baseline |
|
|
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)
|
01/12/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be
conducted to evaluate
and correlate the mesiodistal and faciopalatal horizontal and vertical
dimensions of interproximal area with the presence of interdental papilla and
gingival biotype in maxillary anterior teeth in periodontally healthy males and
females.
Total of 120
subjects with age range of 20-40 years including both male and female visiting
the Department of Periodontics 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 in the age range of 20-40 years.
Group II - 60 periodontally healthy
females in 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 arch
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
view photographs of the subjects will be taken during rest and natural smiling.
Periapical radiographic picture of maxillary anterior teeth using paralleling
cone technique with a XCP device will be recorded with RVG.
Presence and absence of interdental papillae
will be analysed clinically.
On radiograph, the distance from the alveolar
crest to the apical point of the radiopaque material (that is applied to the
tip of the interdental papilla) will be recorded as the vertical dimension of the
interproximal area and the horizontal distance between the
cementoenamel junction of approximal teeth will be recorded as the mesiodistal
horizontal dimension of interproximal papillae.
Digital vernier calliper will be used to
measure faciopalatal dimension of interproximal papillae on alginate impressions.
To determine gingival
thickness, an endodontic spreader with a rubber stopper will be inserted
perpendicularly into the gingiva on the mid buccal aspect of the respective
tooth just 2mm apical to the gingival margin and then this distance from tip of
the endodontic spreader to the rubber stopper will be measured using digital
vernier calliper. |