| CTRI Number |
CTRI/2019/12/022325 [Registered on: 11/12/2019] Trial Registered Prospectively |
| Last Modified On: |
06/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Implants placed with Flap versus Flapless Technique |
|
Scientific Title of Study
|
To evaluate soft tissue and marginal bone changes around dental implants in Flap versus Flapless implant surgical techniques |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DIVYA GANJOO |
| Designation |
Post Graduate Student (MDS) |
| Affiliation |
Shree Bankey Bihari Dental College and Research Centre |
| Address |
Shree Bankey Bihari Dental College and Research Centre. 0.5km Ahead Masuri Canal, N.H. 24, Masuri, Ghaziabad-201302, Uttar Pradesh.
Department Of Periodontics, Room Number 402
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
9582474489 |
| Fax |
|
| Email |
drdivyaganjoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NEHA GUPTA |
| Designation |
Head of Department |
| Affiliation |
Shree Bankey Bihari Dental College and Research Centre |
| Address |
Department Of Periodontics,
Shree Bankey Bihari Dental College and Research Centre. 0.5km ahead Masuri Canal, N.H. 24, Masuri, Ghaziabad-201302, Uttar Pradesh.
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
9971581158 |
| Fax |
|
| Email |
neha.jalaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DIVYA GANJOO |
| Designation |
Post Graduate Student (MDS) |
| Affiliation |
Shree Bankey Bihari Dental College and Research Centre |
| Address |
Room Number 402, Department Of Periodontics,
Shree Bankey Bihari Dental College and Research Centre. 0.5km ahead Masuri Canal, N.H. 24, Masuri, Ghaziabad-201302, Uttar Pradesh.
Ghaziabad
UTTAR PRADESH
201302
India |
| Phone |
9582474489 |
| Fax |
|
| Email |
drdivyaganjoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Divya Ganjoo
Room Number 402, Department Of Periodontics, Shree Bankey Bihari Dental College And Research Centre, Ghaziabad, Uttar Pradesh 201302.
|
|
|
Primary Sponsor
|
| Name |
Dr Divya Ganjoo |
| Address |
Room Number 402, Department Of Periodontics, Shree Bankey Bihari Dental College and Research Centre. 0.5km ahead Masuri Canal, N.H. 24, Masuri, Ghaziabad-201302, Uttar Pradesh. |
| Type of Sponsor |
Other [Individual (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 |
| Dr DIVYA GANJOO |
SHREE BANKEY BIHARI DENTAL COLLEGE AND RESEARCH CENTRE |
Room Number 402, Department Of Periodontics, Shree Bankey Bihari Dental College And Research Centre, 0.5km Ahead Masuri Canal, N.H.-24, Masuri-201302, Ghaziabad (U.P.)
Ghaziabad
UTTAR PRADESH |
9582474489
drdivyaganjoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE SHREE BANKEY BIHARI DENTAL COLLEGE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flap versus Flapless Implant Placement Techniques |
Implants placed with Flap and Flapless Techniques evaluated over 9 months period |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Good periodontal and general health
Adequate amount of bone for implant placement
Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Patients with any systemic disease
Infection
Pregnancy
Smokers
Parafunctional habits |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marginal Bone loss
Probing depth
Width of Keratinized Tissue
Bleeding on Probing (Mombelli et al) |
Baseline, 3 months, 6 months and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient comfort and overall satisfaction |
At 9 months |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
13/12/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a clinical and radiographic study to evaluate soft tissue and marginal bone changes around dental implants in Flap versus Flapless Implant Surgical techniques. This study will comprise of 14 participants reporting to the Out Patient Department of Periodontics at Shree Bankey Bihari Dental College & Research Centre, Ghaziabad (U.P) desiring replacement of missing teeth with dental implants. Written consent will be obtained from each participant. They will be randomly divided into two groups: GROUP A - participants will receive dental implants with Flap Technique; GROUP B - participants will receive dental implants with Flapless Technique. Radiographic evaluation will be carried out at baseline and 9 months after implant placement. Clinical soft tissue evaluation will be carried out at baseline, 3 ,6, 9 months. |