| CTRI Number |
CTRI/2023/12/060668 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate dental implants in smoker patients. |
|
Scientific Title of Study
|
Evaluation of Dental implants with Platelet rich in growth factors (PRGF) in smokers: A split mouth randomised controlled clinical 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 Aastha Singh |
| Designation |
PhD Scholar |
| Affiliation |
King George Medical University. |
| Address |
Department of oral and maxillofacial surgery. New Dental Building.
King Georges Medical University, Lucknow (U.P) -226003
Lucknow
UTTAR PRADESH
208017
India |
| Phone |
9169158477 |
| Fax |
|
| Email |
aastha.singh17891@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uma Shankar Pal |
| Designation |
Professor |
| Affiliation |
King George Medical University. |
| Address |
Department of oral and maxillofacial surgery. New Dental Building.
King Georges Medical University, Lucknow (U.P) -226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415006417 |
| Fax |
|
| Email |
uspal@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aastha Singh |
| Designation |
PhD Scholar |
| Affiliation |
King George Medical University. |
| Address |
Department of oral and maxillofacial surgery. New Dental Building.
King Georges Medical University, Lucknow (U.P) -226003
Lucknow
UTTAR PRADESH
208017
India |
| Phone |
9169158477 |
| Fax |
|
| Email |
aastha.singh17891@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George Medical University, Lucknow-226003 (U.P.), India. |
|
|
Primary Sponsor
|
| Name |
Dr Aastha Singh |
| Address |
Department of oral and maxillofacial surgery, New Dental Building, King George Medical University, Lucknow-226003 (U.P.), India. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| King George Medical University |
King George Medical University, Lucknow-226003 (U.P.), India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aastha Singh |
New Dental Building, King George Medical University, Lucknow -226003, India |
Department of oral and maxillofacial surgery,
First floor (OPD Room),
Room No-1.
Lucknow
UTTAR PRADESH |
9169158477
aastha.singh17891@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University U.P., Institutional Ethics Committee, Lucknow (INDIA). |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional spiral implants placement without PRGF. |
Control site- Conventional implant placement without PRGF in each moderate smoker patient with identical edentulous site. |
| Intervention |
Maintained Active Implant with platelet rich in growth factors (PRGF). |
Test Site-
-Maintained Active Implant are spiral design implants but with innovative hollowed platform and with few points of holes in the body to deliver regenerative substances i.e., Platelet Rich in Growth Factors (PRGF). Mainly used in moderate smoker s for rehabilitation of edentulous sites.
-After 1month of healing period, only at the MAI implant site once again PRGF is injected, and implant closed by cover screw. After healing period of 3-4 months, implants will be exposed, and screw retained abutment will be placed on both sites and patient will be subjected to prosthodontic treatment.
-Each patient will be assessed at the time of fixture placement, after 3 months (at the time of loading), and at 6 months after loading.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderate smokers (>10 and <20 cigarettes per day from last 10 years) who is willing to quit smoking.
2. Healed sites without bone grafting / bone defects for at least 3 months.
3. Periodontally healthy teeth adjacent to the implant sites and without any periapical lesion.
4. Identical edentulous spaces in either of the arches with adequate bone volume.
|
|
| ExclusionCriteria |
| Details |
1. Patients consuming any other form of tobacco other than cigarette smoking and alcohol consumption.
2. Pregnant and breast-feeding females.
3. Immunosuppressive health or any systemic disease or disorder like diabetes mellites, immune-viral diseases, hepatic and renal diseases, bone related disorders etc.
4. Subjects with local or systemic drug use like bisphosphonates, NSAID’S antibiotics or corticosteroids etc. from last 3 months.
5. Bruxism or other oral para functional habits.
6. Subjects with history of any surgical or peri-implant treatment.
7. Maligned teeth or edentulous patients.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing of peri-implant soft tissues and marginal bone loss especially in cases of smokers by modification of implant design along with PRGF to shorten the healing time and bone and implant contact.
|
Dividing patient visits in following stages: -
1-Fixture placement along with PRGF at test site and control site with conventional fixture only. Baseline recordings.
2.At 1 month, PRGF will be injected at site with MAI implant only.
3.At 3-4 months abutment placement.
4.At 6 months after loading. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To evaluate aesthetic outcomes.
•Patient compliance and experience.
|
- Aesthetic outcomes:
• Pink esthetic score
• White esthetic score
-Post operative pain and healing after 24 hours of surgery, 1weeks and at 1month follow up period.
|
|
|
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)
|
22/01/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
There are various options for regeneration of bone around the implant like autogenous bone graft, demineralized freeze-dried bone (DFDB), Platelet rich in growth factors (PRGF) etc. autogenous bone graft have drawback of donor site morbidity, DFDB is more prone to infection and rejection while PRGF is one of the promising choices which is having least complications with no donor site morbidity. Apart from other qualities economically it seems to be the best choice till date. So, in this study we have chosen PRGF and are going to evaluate its efficacy in bone formation. A systematic review also suggested that Platelet rich fibrin might enhance implant stability during early phase of osseointergration (Strauss et al. 2018). Many attempts have been made to attain ultimate primary as well as secondary stability (osseointegration) by modifying macro as well as micro design of dental implants. Recently, Maintained Active Implants (MAI) has been introduced which is based on spiral design implants but with innovative hollowed platform and with few points of holes in the body to deliver regenerative substances to ensure bone preservation and internal osseointegration with years to come. However, there is lacunae in the available literature regarding the PRGF delivery at the healing site and its outcome by this design of dental implant. From this we try to overcome the limitations of the available dental implants in healing of peri-implant soft tissues and marginal bone loss especially in cases of smokers which have high prevalence of implant failure. Few literatures, especially split mouth randomised controlled trial, are available to overcome the adverse effects of smoking, PRGF is used and its effect on peri-implant soft tissues, marginal bone loss and to establish primary stability that is crucial phase for implant survival. So, we are attempting to evaluate the effect of PRGF on bony and soft tissue integration of the dental implant in moderate cigarette smokers. In this study delivery system of the regenerative material and implant design is different from the studies conducted till date.
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