| CTRI Number |
CTRI/2023/10/058921 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
08/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Flapless and Open flap technique for Implant placement |
|
Scientific Title of Study
|
A comparative evaluation of Flapless versus Open Flap technique for Implant placement |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Sneha |
| Designation |
PG Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room no. 2 Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Chaudhary Vihar Raebareilly road, Utrathia, Lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
8660071672 |
| Fax |
|
| Email |
ruchisneha15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gaurav Singh |
| Designation |
Pricipal, Professor and Head of the Department |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room no. 2, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Chaudhary Vihar Raebareilly road, Utrathia, Lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
9415086536 |
| Fax |
|
| Email |
dr.gaurav1502@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Sneha |
| Designation |
PG Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room no.2, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Chaudhary Vihar Raebareilly road, Utrathia, Lucknow
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
8660071672 |
| Fax |
|
| Email |
ruchisneha15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, SPPGIDMS, Lucknow |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Chaudhary Vihar Raebareilly road, Utrathia, Lucknow |
| 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 |
| Ruchi Sneha |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Room no. 2, Department of Oral and Maxillofacial Surgery
Lucknow
UTTAR PRADESH |
8660071672
ruchisneha15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Sardar Patel Post Graduate Institute of Dental and Medical Sciencess |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteer with bilateral missing molars in the mandible with adequate bone volume requiring dental implants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
flapless technique |
The surgical field will be prepared and isolated and the area will be anesthetized using 2% xylocaine hydrochloride with epinephrine (1:80,000).In this technique, instead of elevation of flap, with the use of tissue punch guide according to implant size, soft tissue is punched out with the tissue punch followed by osteotomy using a pilot drill of 2mm through surgical template. Subsequent drilling will be done to prepare the site according to the selected implant size. After the complete embedding of the endo-osseous root form implant into the bone, secondary healing cap will be tightened over the implant to allow tissue healing. |
| Comparator Agent |
open flap technique |
The surgical field will be prepared and isolated and the area will be anesthetized using 2% xylocaine hydrochloride with epinephrine (1:80,000). At the implant recipient site of the Group B, a midcrestal incision will be made and a sulcular incision on the mesial aspects of the adjacent teeth with a Bard-Parker blade No. 15, and a full-thickness flap will be elevated. The pilot drill will be then used to the required depth. The site will be prepared to the required diameter to receive the appropriate implant. The endo-osseous root form implants will be then placed into the osteotomy site and the flaps were approximated and sutured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade I,II patients
2.Patient with bilateral missing mandibular molars.
3.Patient age between 18-40 years
4,Good oral hygiene
5.Adequate bone volume for implant placement
|
|
| ExclusionCriteria |
| Details |
1. Patient with complicated medical history such as uncontrolled diabetes, bleeding disorders, osteoporosis; patients on radiation therapy; and immunocompromised states.
2. Untreated periodontitis
3. Smokers
•Patients with parafunctional habits.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The possible outcome of this study will be to see the lesser reduction in crestal bone height, better peri-implant health and would healing using flapless technique than open flap technique for implant placement |
At baseline,1st day, 3rd day, 5th day, 7th day, 4 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Successful dental implant surgery providing patients with teeth in missing dental segments with; decreased surgical time; improved patient comfort; & accelerated recuperation, allowing the patient to resume normal oral hygiene procedures immediately after the procedure |
at baseline, 1st day, 3rd day, 5th day, 7th day, 4 months & 6 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
|
N/A |
|
Date of First Enrollment (India)
|
19/10/2023 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ruchisneha15@gmail.com].
- For how long will this data be available start date provided 14-07-2023 and end date provided 14-08-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present above mentioned Thesis " A comparative evaluation of flapless vs open flap technique for implant placement " is to evaluate and compare
the effect of flapless and “open flap†technique of implant placement on
crestal bone height around implants. It is going to be held over a period of 2 years. The study shall be carried
out on patients having bilateral missing mandibular molars in the out-patients department of Oral and Maxillofacial surgery in Sardar Post
Graduate Institute of Dental and Medical Sciences. Patient will be selected according to inclusion criteria and a
sample size of 20 patients which includes patients those having bilateral
missing molar and will be randomly allocated to Group A and Group B. In Group A
implant will be placed using flapless technique and in Group B by using open
flap technique.
In case of “flapless†technique, with the use of tissue punch
guide according to implant size, soft tissue is punched out with the tissue
punch followed by osteotomy using a pilot drill of 2mm through surgical
template. Subsequent drilling will be done to prepare the site according to the
selected implant size. After the complete embedding of the endo-osseous root
form implant into the bone, secondary healing cap will be tightened over the
implant to allow tissue healing. Another implant will be placed on the opposite
edentulous site using “open flap†technique by reflecting mucoperiosteal flap.
IOPA radiograph will be taken after the procedure to confirm complete insertion
of the implant. Postoperative antibiotics and analgesics will be prescribed to
the patient for 5 days. Patient will be followed up for 6 months after implant
placement and assessed for post operative pain, wound healing, peri-implantitis,
papillary index and crestal bone height. The crestal bone height will be
measured using IOPA. All the participants involved in this study will be
advised for IOPA at the time of placement and post operatively 6 months after
the implant placement. |