| CTRI Number |
CTRI/2025/04/083947 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Comparing Two Methods of Dental Implant Placement in the Front of the Upper Jaw: A Study on Socket Shields vs. Traditional Immediate Implants" |
|
Scientific Title of Study
|
socket shield technique versus conventional immediate implant placement in anterior maxillary region-A randomised prospective comparative 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 Shreya Joshi |
| Designation |
PG Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
02,Department of oral and maxillofacial, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
department of oral and maxillofacial surgery,Sardar patel post graduate institute of dental and medical sciences
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8874894661 |
| Fax |
|
| Email |
shreyajoshi910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madan Mishra |
| Designation |
Professor |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
02,Department of oral and maxillofacial, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
02,Department of oral and maxillofacial, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9565740127 |
| Fax |
|
| Email |
mm.15mds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madan Mishra |
| Designation |
Professor |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
02,Department of oral and maxillofacial, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
02,Department of oral and maxillofacial, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9565740127 |
| Fax |
|
| Email |
mm.15mds@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of oral and maxillofacial surgery,sardar patel post graduate institute of dental and medical sciences,Lucknow |
|
|
Primary Sponsor
|
| Name |
Sardar patel post graduate institute of dental and medical sciences |
| Address |
Raebareilly road Lucknow-226025 |
| Type of Sponsor |
Research institution |
|
|
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 Shreya Joshi |
Sardar patel Post Graduate Institute of Dental and Medical Sciences |
department Number 2,Department of oral and maxillofacial surgery
Lucknow
UTTAR PRADESH |
8874894661
shreyajoshi910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
preventive and screening intervention on volunteers with damaged maxillary anterior teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional immediate implant placement |
patients tooth extraction will be done followed by immediate implant placement without leaving any portion of the tooth root in the extraction socket.Closure will be done using 3-0 mersilk suture and patient will be evaluated for post operative pain and wound healing on 1st,3rd ,5th and 7th day ;for implant mobility, periimplantitis on 4th and 6th month, for implant stability at the time of implant placement and 6th month; for radiographic evaluation of buccal crestal bone height at pre-operative, immediate post operative ,4th month and 7th month. |
| Intervention |
socket shield technique |
patients tooth extraction will be done by socket shield technique with the sequential use of burs. In the first step tooth crown will be sectioned at the cervical level followed by sectioning the tooth mesio-distally. This will split the roots labially and palatally followed by atraumatic removal of palatal portion of root. Thus the labial wall of root will be left intact and will be contoured in cresent shape. Now the site for implant placement will be prepared by sequential drilling, surrounded by tooth root on buccal side and bone on palatal side.Closure will be done using 3-0 mersilk suture and patient will be evaluated for post operative pain and wound healing on 1st,3rd ,5th and 7th day ;for implant mobility, periimplantitis on 4th and 6th month, for implant stability at the time of implant placement and 6th month; for radiographic evaluation of buccal crestal bone height at pre-operative, immediate post operative ,4th month and 7th month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist Classification (ASA) I and II patient.
1. Patients under Sagital Root Position classification (SRP) class I and class II
2. Patients with fractured maxillary anteriors without fractured cortical plates or any associated pathology
3.Patients age between 18-40 years
4.Good oral hygiene
5.Adequate bone volume for implant placement |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome is to evaluate Mobility (Misch’s Clinical implant stability),Implant Primary and secondary stability (Osstell),Measurement of the amount of vertical and horizontal bone loss as seen on CBCT (Cone Beam Computed Tomography). |
estimated time may range upto 7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome is to evaluate pain,wound healing,paillary index and periimplantitis |
estimated time may range upto 7months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
Months="7"
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
|
The study shall be carried out on patients attending the Out Patient Department (OPD) of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, with permission from Institutional Ethical Committee (IEC). A written informed consent will be obtained from each patient after explaining the nature and outcome of procedure and the possible consequences and complications. Patient will be selected irrespective of caste, creed, sex, religion or socio-economic status.Each patient will be randomly allocated to group I and group II using lottery method.All the cases will undergo thorough history taking and clinical examination. Radiographs will be taken (CBCT). Routine blood investigations and viral markers will be done. Two groups will be made and patient will be randomly allocated to Group A (Socket shield technique) and Group B (conventional immediate implant placement). Following consent the surgical field will be prepared and isolated and area will be anesthetized using 2% Xylocaine hydrochloride with epinephrine (1: 80,000). In Group A patients tooth extraction will be done by socket shield technique with the sequential use of burs. In the first step tooth crown will be sectioned at the cervical level followed by sectioning the tooth mesio-distally. This will split the roots labially and palatally followed by atraumatic removal of palatal portion of root. Thus the labial wall of root will be left intact and will be contoured in cresent shape. Now the site for implant placement will be prepared by sequential drilling, surrounded by tooth root on buccal side and bone on palatal side. While in Group B patients tooth extraction will be done followed by immediate implant placement without leaving any portion of the tooth root in the extraction socket. Closure in both group A and group B patients will be done using 3-0 mersilk suture and patient will be evaluated for post operative pain and wound healing on 1st,3rd ,5th and 7th day ;for implant mobility, periimplantitis on 4th and 6th month, for implant stability at the time of implant placement and 6th month; for radiographic evaluation of buccal crestal bone height at pre-operative, immediate post operative ,4th month and 7th month. Post operatively analgesics and antibiotics will be prescribed for 5 days. The patients will be advised to maintain proper oral hygiene. Radiographs and photographs will be taken prior to extraction procedure and during follow ups at regular intervals.
|