| CTRI Number |
CTRI/2025/06/089700 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying changes in gums and bone in upper front teeth after placing fixed crowns |
|
Scientific Title of Study
|
Evaluating the clinical and tomographic changes in the periodontium after fixed prosthesis placement in the esthetic zone : An experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Agrawal |
| Designation |
Post Graduate Student |
| Affiliation |
Manubhai Patel Dental College and Hospital & ORI |
| Address |
Ground floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near Vishwamitri bridge
Munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT
390011
India |
| Phone |
9426538306 |
| Fax |
|
| Email |
prachiagarwal3037@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshini Nadig |
| Designation |
Professor |
| Affiliation |
Manubhai patel dental college and hospital & ORI |
| Address |
Ground floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near Vishwamitri bridge
munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT
390011
India |
| Phone |
7567796090 |
| Fax |
|
| Email |
priya_darshinikud@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshini Nadig |
| Designation |
Professor |
| Affiliation |
Manubhai patel dental college and hospital & ORI |
| Address |
Ground floor Department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near Vishwamitri bridge
munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT
390011
India |
| Phone |
7567796090 |
| Fax |
|
| Email |
priya_darshinikud@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Prachi Agrawal Department of periodontics and implantology
Manubhai Patel Dental College and Hospital and ORI Vishwajyoti
ashram near Vishwamitri bridge Munjmahuda
Vadodara
GUJARAT
390011
India |
|
|
Primary Sponsor
|
| Name |
Dr Prachi Agrawal |
| Address |
Department of Periodontics and Implantology
Manubhai Patel Dental College and Hospital and ORI Vishwajyoti
ashram near Vishwamitri bridge Munjmahuda
Vadodara
GUJARAT
390011
India |
| 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 Prachi Agrawal |
Manubhai Patel Dental College and Hospital and ORI |
Ground floor Department of Periodontics and Implantology
Manubhai Patel Dental College and Hospital and ORI
Vishwajyoti ashram near Vishwamitri bridge Munjmahuda
Vadodara
GUJARAT
390011
India
Vadodara
GUJARAT |
9426538306
prachiagarwal3037@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research, Manubhai Patel Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual without systemic disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age more than or equal to 18 years
Periodontally and systemically healthy subjects
Teeth selected as abutments in maxillary anterior region (maxillary right first premolar to left first premolar) undergoing fixed prosthesis replacement (including smile design veneers, single crowns, bridges etc)
Subjects giving the written informed consent
|
|
| ExclusionCriteria |
| Details |
Implant fixed prosthesis in the anterior maxilla
Subjects taking systemic medications that may affect the periodontium (e.g., phenytoin, calcium channel blockers, cyclosporin, etc.)
Subjects with a history of previous periodontal plastic surgeries in the anterior maxilla region
Presence of sites with active periodontal disease/ reduced periodontium
Lower mandibular teeth
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pocket probing depth 2.Keratinized tissue width 3.Gingival recession
4.Gingival biotype |
Changes in
1.Pocket probing depth 2.Keratinized tissue width 3.Gingival recession
4.Gingival biotype
after fixed prosthesis placement from baseline to 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Buccal bone alveolar crest levels
2.Buccal bone thickness |
Evaluate changes in
1.Buccal bone alveolar crest levels after fixed prosthesis treatment from baseline to 6 months.
2.Buccal bone thickness after fixed prosthesis treatment from baseline to 6 months.
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate the clinical and tomographic changes in the periodontium after fixed prosthesis placement in the esthetic zone. To evaluate the changes in pocket probing depth, keratinized tissue width, gingival recession and gingival biotype, buccal bone alveolar crest levels and buccal bone thickness after fixed prosthesis placement from baseline to 6 months. |