| CTRI Number |
CTRI/2024/06/069392 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of surrounding Periodontal Hard and Soft Tissue Thickness on Dental Implant Stability |
|
Scientific Title of Study
|
Evaluation and Comparison of Dental Implant Stability and Crestal Bone Level Around Implant in Patients with Thin Versus Thick Buccal Cortical Plate with Gingival Biotype Assessment A Clinico Radiographic 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 Gunjan Aggarwal |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana |
| Address |
Room no-11, Department of Periodontology, SGT Dental College, Hospital and Research Institute, Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9205630689 |
| Fax |
|
| Email |
gunjanaggarwal1298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhardwaj |
| Designation |
Professor and Head , Department of Periodontology |
| Affiliation |
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana |
| Address |
Room no 11, block b SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana-122505
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9818718872 |
| Fax |
|
| Email |
amit.bhardwaj@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhardwaj |
| Designation |
Professor and Head , Department of Periodontology |
| Affiliation |
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana |
| Address |
Room no 11, block b SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana-122505
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9818718872 |
| Fax |
|
| Email |
amit.bhardwaj@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Room no-11, Department of Periodontology, SGT Dental College, Hospital and Research Institute, Gurugram Haryana- 122505 |
|
|
Primary Sponsor
|
| Name |
SGT Dental College Hospital and Research Institute SGT University Gurugram Haryana |
| Address |
Room no-11, Department of Periodontology, SGT Dental College, Hospital and Research Institute, Gurugram Haryana- 122505 |
| Type of Sponsor |
Private medical college |
|
|
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 Gunjan Aggarwal |
SGT Dental College, Hospital and Research Institute |
Room no-11, Department of Periodontology, SGT Dental College, Hospital and Research Institute, Gurugram Haryana- 122505
Gurgaon
HARYANA |
9205630689
gunjanaggarwal1298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- SGT Dental College , Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Crestal Bone Level |
Crestal Bone level will be measured and compared in patients having thin and thick buccal cortical plates at the time of placement of implant and after 3 months |
| Intervention |
Dental Implants |
Dental implants will be placed in patients having edentulous site |
| Comparator Agent |
Implant Stability Quotient |
Implant stability Quotient will be measured at the time of placement and will be compared after 3 months in patients having thin and thick buccal cortical plate |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 25-60 years inclusive of both genders
2.Patients with minimum 1 edentulous site
3.Patients able to understand and sign a consent form
4.Patients who are systemically healthy
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from periodontitis
2.Patients with adverse habits like smoking and parafunctional habits
3.Patients with immunocompromised conditions
4.Pregnant and nursing women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate implant stability in patients with thin and thick buccal cortical at baseline and at the second stage surgery.
2.To evaluate crestal bone level around implant in patients with thin and thick buccal cortical plate at baseline and at the second stage surgery.
|
1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare implant stability in patients with thin & thick buccal cortical plate at baseline & at the second stage surgery.
2.To compare crestal bone level around implant in patients with thin & thick buccal cortical plate at baseline & at the second stage surgery.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Previously, studies related to buccal cortical plate thickness and gingival biotype has been done separately in relation to implant study and crestal bone level and not in single study. Hence, this study aims to evaluate and compare the dental implant stability and crestal bone level around dental implants in patients with thin versus thick buccal cortical plate. This study is the new to correlate the buccal cortical plate thickness and gingival biotype of the patient with implant stability and crestal bone level around dental implants. Patients requiring dental implants will be categorised on the basis of thin and thick buccal cortical plate and gingival biotype on the basis of CBCT evaluation and transgingival probing respectively. ISQ VALUE and crestal bone level will be assessed at baseline at 3 months post operatively. We expect a weak correlation between cortical bone thickness and gingival biotype with implant stability and crestal bone level, however any new interpretation will be interesting to know. |