| CTRI Number |
CTRI/2024/08/073071 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two Different Dental Implant Placement Technique |
|
Scientific Title of Study
|
Comparative Assessment of Implant Placement by using Conventional Versus Flapless Technique: A Prospective Clinical 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 |
PRATIBHA |
| Designation |
Post- graduate student (MDS) |
| Affiliation |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital, sector 25, Chandigarh |
| Address |
Room No 5,
Department of Oral & Maxillofacial Surgery,
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital,
Sector 25,
Panjab University,
Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9988290658 |
| Fax |
|
| Email |
lambapratibha2494@protonmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HEMANT BATRA |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital, Sector 25, Chandigarh |
| Address |
Room No 5,
Department of Oral & Maxillofacial Surgery,
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital,
Sector 25,
Panjab University,
Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9814555550 |
| Fax |
|
| Email |
hemantbatra@pu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
PRATIBHA |
| Designation |
POST GRADUATE STUDENT (MDS) |
| Affiliation |
Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital, Sector-25, Chandigarh |
| Address |
Room No 5,
Department of Oral & Maxillofacial Surgery,
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital,
Sector 25,
Panjab University,
Chandigarh
Chandigarh
CHANDIGARH
160014
India |
| Phone |
9988290658 |
| Fax |
|
| Email |
lambapratibha2494@protonmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Harvansh Singh Judge Institute of Dental Sciences And Hospital, Sector- 25, Panjab University, Chandigarh, India, 160014 |
|
|
Primary Sponsor
|
| Name |
Dr Harvansh Singh Judge Institute of Dental Sciences And Hospital |
| Address |
Sector- 25, Panjab University, Chandigarh, India, 160014 |
| Type of Sponsor |
Government 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 PRATIBHA |
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital |
Room No 5,
Department of Oral & Maxillofacial Surgery,
Dr Harvansh Singh Judge Institute of Dental Sciences and Hospital,
Sector 25,
Panjab University,
Chandigarh
Chandigarh
CHANDIGARH |
9988290658
lambapratibha2494@protonmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PANJAB UNIVERSITY(PUIEC), CHANDIGARH- 160014 |
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 |
| Intervention |
Implant Placement By Conventional Flap Technique |
After achieving adequate local anaesthesia, mid-crestal incisions will be placed on the edentulous site indicated for implant placement with No.15 B.P. blade. Incisions would also be extended to the mid buccal region of adjacent tooth. Full thickness flap will be elevated using molt’s periosteal elevator. |
| Comparator Agent |
Implant Placement By Flapless Technique |
After achieving adequate local anaesthesia, a circular tissue punch will be used to remove the mucosa prior to the use of the round bur. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 25-55 years.
2.Patients with edentulous spaces indicated for implant placement.
3.Patients who are willing to comply with the treatment regimen.
4.Patients with history of extraction not less than 6 months.
5.Patients with health status ASA I & ASA II.
6.Patients with adequate width of attached gingiva. |
|
| ExclusionCriteria |
| Details |
1.Pregnant females.
2.Lactating mothers.
3.Patients with uncontrolled systemic diseases contraindicating any type of surgery.
4.Patients who are not willing to participate in the study or come for follow-up.
5.Patients with any contraindications for implant placement.
6.Patients undergoing radiation therapy or history of radiation therapy in head and neck region.
7.Patients who are smokers and alcoholics. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. duration of surgery
2. pain
3. swelling
|
1. intraoperatively
2. at night of surgery, day 1 to 7
3. at day 1, 3 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| marginal bone loss |
at 1 month, 2 months and 3 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
09/09/2024 |
| 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 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
|
this is a randomized control clinical prospective study comparing the outcomes of conventional flap and flapless implant techniques in 32 patients over the course of 18 months. patients fulfilling inclusion criteria will be recruited and informed consent will be taken. following randomization, surgical procedure will be performed according to established protocol. preoperative assessments including clinical photographs and CBCT scans will be done to evaluate the implant site. surgical interventions will be meticulously executed with postoperative evaluation focusing on parameters such as surgical time, pain, swelling and marginal bone loss assessed using IOPAR and CBCT at designated intervals. post operative care instructions will be provided to ensure patients well-being and facilitate optimal healing. |