| CTRI Number |
CTRI/2024/01/061312 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of tissue healing of implants placed immediately after removal of teeth in esthetic zone using Sohns Poncho technique vs the conventional technique |
|
Scientific Title of Study
|
Comparative Evaluation of Tissue Healing By using Sohn’s Poncho Technique vs Conventional Technique In Immediate Dental Implants Placed In Esthetic Zone – A Randomised Controlled Trial |
| 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. Korambeth Shreeya Manojkumar |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and hospital, Nagpur |
| Address |
Department no. 202, second floor, Government dental college and hospital, Hanuman Nagar, Nagpur
MAHARASHTRA
440003
India
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9833315754 |
| Fax |
|
| Email |
shreeyak88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Karemore |
| Designation |
Associate professor |
| Affiliation |
Government dental college and hospital, Nagpur |
| Address |
Department no. 202, second floor, Government dental college and hospital, Hanuman Nagar, Nagpur
MAHARASHTRA
440003
India
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9011098882 |
| Fax |
|
| Email |
drperiodon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Korambeth Shreeya Manojkumar |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and hospital, Nagpur |
| Address |
Department no. 202, second floor, Government dental college and hospital, Hanuman Nagar, Nagpur
MAHARASHTRA
440003
India
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9833315754 |
| Fax |
|
| Email |
shreeyak88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital, Haunman Nagar, Medical square, Nagpur-440003
|
|
|
Primary Sponsor
|
| Name |
Dr. Korambeth Shreeya Manojkumar |
| Address |
Department no. 202, department of periodontology, second floor, Government dental college and hospital , Medical square, Hanuman Nagar, Nagpur-440003 |
| Type of Sponsor |
Other [Self sponsor] |
|
|
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 Korambeth Shreeya Manojkumar |
Government dental college and hospital Nagpur |
Department no.202, department of periodontology, Medical square, Hanuman nagar, Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9833315754
shreeyak88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional technique |
Patients with immediate dental implants placed using conventional technique in esthetic zone with 6 months follow up period |
| Intervention |
Sohn’s Poncho technique |
Patients receiving immediate dental implants placed using Sohn’s Poncho technique in esthetic zone with 6 months follow up period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
a)Systemically healthy patients requiring and opting dental
implants for replacement of missing teeth in anterior
esthetic zone
b) Patients above 18yrs of age
c) Good oral hygiene and periodontal status |
|
| ExclusionCriteria |
| Details |
1)Patient with systemic disease that contraindicates the surgery immunocompromised patients
2)Pregnant or lactating females
3)History of radiotherapy smokers parafunctional habits acute and chronic infection
4)Noncompliant patients
5)Active pathology associated with site of interest |
|
|
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 of soft tissue healing around immediate dental implants placed in esthetic zone |
assessment at 3 and 6 months post implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of hard tissue healing around immediate dental implants placed in esthetic zone |
Assessment post implant placement and post 6 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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="0" |
|
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
|
In the past few decades, Implant therapy has evolved as a successful treatment for edentulism whether partial or complete. Replacement of missing tooth with implants has added advantages over other options such as removable partial denture or fixed partial denture which include preservation of alveolar crest and elimination of need to restore neighbouring teeth along with advantage of improved esthetics and functions. The original protocol suggested placement of implants after a healing period of 3-6 months following tooth extraction. Conventional loading protocols have prolonged healing periods which is troublesome to the patient because of functional and esthetic reasons. Dental implants can also be placed immediately after tooth extraction. Immediate implants allow placement of the implant at the same visit at which the tooth is extracted, which helps to reduce the number of surgical procedures and hence the overall treatment time. They also help to preserve alveolar width and height. When an implant is placed in a fresh extraction socket, a gap may occur between the implant surface and the bony socket wall. While delayed implants offers the time required for soft tissue to grow into the extraction socket making their attachment to implants more predictable, immediate implants poses a significant risk of bacterial contamination because of insufficient soft tissue volume. PRF (platelet rich fibrin) has been recently indicated as an aid for promoting hard and soft tissue regeneration. It is a second generation of platelet derivative enriched with platelets, leukocytes and growth factors . It also contains all the molecular and cellular elements required for optimal healing. Sohn’s poncho technique is a surgical method that utilizes the healing capacity of PRF (platelet rich fibrin) or CGF(concentrated growth factor) membranes through stabilizing the membrane with help of healing or prosthetic abutment at implant site in order to perform minimally invasive GBR (guided bone regeneration) procedure.. After extensive search of literature no study was found comparing Sohn’s Poncho technique with the conventional technique of immediate dental implant placement in esthetic zone. Thus, this study aims to establish a comparison and highlight the merit (if any) of any one technique. Primary hypothesis: There is statistically significant difference in tissue healing of immediate dental implants placed using Sohn’s Poncho technique and conventional technique in esthetic zone.
Null Hypothesis: There is no statistically significant difference in tissue healing of immediate dental implants placed using Sohn’s Poncho technique and conventional technique in esthetic zone
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