| CTRI Number |
CTRI/2023/03/050583 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
09/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare bone marker levels and implant stability immediately placed dental implants using two different techniques in upper front tooth region of the jaw. |
|
Scientific Title of Study
|
A comparative study to evaluate the alkaline phosphatase level and implant stability quotient in immediate implants placed by using socket shield technique and conventional technique in maxillary anterior region - a randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harish Vasant Mange |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
2nd floor, Department of Prosthodontics, Centre for Medical Education and Research, All India Institute of Medical Sciences, Ansari Nagar East, Ansari Nagar, Delhi.
New Delhi
DELHI
110029
India |
| Phone |
7208240493 |
| Fax |
|
| Email |
harimange@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Nanda |
| Designation |
Assitant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
2nd floor, Department of Prosthodontics, Centre for Medical Education and Research, All India Institute of Medical Sciences, Ansari Nagar East, Ansari Nagar, Delhi.
East
DELHI
10029
India |
| Phone |
9871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Nanda |
| Designation |
Assitant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
2nd floor, Department of Prosthodontics, Centre for Medical Education and Research, All India Institute of Medical Sciences, Ansari Nagar East, Ansari Nagar, Delhi.
North
DELHI
10029
India |
| Phone |
9871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Harish Mange |
| Address |
Centre for Dental Education and Research, All India Institute Of Medical Sciences, ANSARI NAGAR, NEW DELHI -110029 |
| 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 |
| Harish Vasant Mange |
Centre for Dental Education and Research |
2nd floor ,Department of Prosthodontics ,CDER, opposite New RAK OPD, AIIMS,New Delhi
New Delhi
DELHI |
7208240493
harimange@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESERACH ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAG AR, NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Implant placement using conventional technique |
Evaluate the alkaline phosphotase level and implant stability quotient in immediate implants at 2,6 and 12 weeks after implant placement following the conventional technique |
| Intervention |
Implant placement using socket shield technique |
Evaluate the alkaline phosphotase level and implant stability quotient in immediate implants at 2,6,and 12 weeks after implant placement following the socket shield technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having any compromised maxillary anterior tooth/teeth indicated for extraction.
2. Patients having intact buccal periodontal tissues.
3. Patients in the age range of 18-45 years
4. Good oral hygiene and periodontal status of remaining dentition. Full
mouth plaque and the bleeding score of 15 % or less
5. Non-smoker.
6. Free from systemic diseases
affecting gingival health and osseointegration.
7. With positive informed consent
and available for treatment and follow-up. |
|
| ExclusionCriteria |
| Details |
1. Metabolic or systemic disease.
2. Teeth with vertical root fractures on the buccal aspect.
3. Teeth with horizontal root fractures below bone level.
4. Placement of bone graft during implant placement
5. History of irradiation in the head or neck area.
6. Pregnant or lactating women.
7. Para functional habits
8. Untreated generalized periodontitis
9. Poor oral hygiene and motivation.
10. Psychiatric disorders or unrealistic expectations.
11. Acute infection (abscess) in
the site intended for implant placement.
12. Under treatment or had previous treatment with bisphosphonates.
13. Insertion torque during implant placement < 35Ncm. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation and comparison of Alkaline phosphatase level in Peri implant sulcular fluid in maxillary anterior immediate implants placed by using socket shield technique and conventional technique. |
2 weeks, 6 weeks and 12 weeks after implant placement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation and comparison of implant stability quotient in maxillary anterior immediate implant placed by using Socket sheild technique and conventional technique. |
Immediately after implant placement (baseline), 2 weeks,6 weeks and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Socket shield technique has been a modification in immediate imlant placement has has advantages like buccal portion of the bone and PDL on buccofacial aspect of the implant are preserved, especially in anteriors where the buccal cortical plate is thin.It is a single surgical procedure with no additional material cost and no added co-morbidities over conventional immediate implant. Our study aims to compare both the techniques of biochemical levels in which we wil be comparing the levels of alkaline phosphates in socket shield and conventional technique of implant placement over the time range of 2 weeks, 6 weeks and 12 weeks post implant placement also we would be comparing implant stability quotient in both the groups immediately post implant placement, 2 weeks ,6 weeks and 12 weeks. |