| CTRI Number |
CTRI/2024/04/066238 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Study: Examining Two Implant Systems for Treating Patients with Missing Teeth |
|
Scientific Title of Study
|
Comparative evaluation of clinical and radiographic outcomes of two commercially available implant systems for treating partially edentulous patients – a prospective 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 |
Dr Shreya Singh |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT dental college and hospital |
| Address |
G-02
Department of Periodontics
SMBT Dental college and hospital
amrutnagar
Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9820951819 |
| Fax |
|
| Email |
shreyasingh991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purushottam Rakhewar |
| Designation |
Professor and Head of Department |
| Affiliation |
SMBT Dental college and Hospital |
| Address |
G-02
Department of Periodontics
SMBT Dental college and
hospital
Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purushottam Rakhewar |
| Designation |
Professor and Head of Department |
| Affiliation |
SMBT Dental college and Hospital |
| Address |
G-02
Department of Periodontics
SMBT Dental college and
hospital
amrutnagar
Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental college and Hospital,amrutnagar,sangamner-422608 |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [none] |
|
|
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 Shreya Singh |
SMBT Dental college and hospital |
G-02 Department of
Periodontics
Sangamner
Ahmadnagar
MAHARASHTRA |
9820951819
shreyasingh991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Commitee on Ethics, SMBT Dental College,Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Placement of Adin implants in partially edentulous patients |
Adin implants will be placed in partially edentulous patients and then will be evaluated for to assess the clinical and radiographic changes and the resultant outcome after
placement of implant at stage 1 surgery, stage 2 surgery, 6 months and 1
year follow up |
| Comparator Agent |
Placement of Osstem implants in partially edentulous patients |
Osstem implants will be placed in partially edentulous patients and then will be evaluated for to assess the clinical and radiographic changes and the resultant outcome after placement of implant at stage 1 surgery, stage 2 surgery, 6 months and 1 year follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Partially edentulous patient requiring 1 or more single implant supported crown
2)Absence of any local anatomical limitations
3)Patient willing for surgery |
|
| ExclusionCriteria |
| Details |
1)General contraindications to implant surgery
2)Local and systemic conditions affecting bone
3)Poor oral hygiene and motivation
4)Untreated periodontitis or acute/purulent infection in the area intended for implant
placement
5)Unable to commit to 1-year follow-up
6)Treated or under treatment with intravenous amino-bisphosphonates
7)Lacking antagonistic occlusal surfaces for the study implants at implant loading
8)Implant site requiring major bone grafting procedures including sinus lift with lateral
approach, minor augmentation procedures such as crestal sinus lift. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluation of implant
stability quotient |
at baseline that is after stage 1 surgery, after stage 2 surgery , 6 months and
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate marginal bone level |
at baseline to one year |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="0"
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
|
Aim of the study is to evaluate and compare the clinical and radiographic outcomes of two different implant systems Adin and Osstem in the treatment of partially edentulous arches. All the participants will be explained the need and design of the study. Informed and written consent will obtained from the patients. Thorough clinical case history will be recorded. A full mouth supragingival and subgingival scaling and root planing procedure will be performed. 2 weeks after phase I therapy, a clinical and radiographic evaluation will be performed to confirm the suitability of the sites for this study. The selected sites will be divided randomly into A and O groups. Group A will be treated with ADIN implants, whereas group O will be treated with OSSTEM implants. Clinical parameters like pain intensity from implant region using visual analogue scale (VAS), implant stability using the first generation Osstell instrument , modified plaque index (PI) , modified sulcus bleeding index, probing pocket depth, width of masticatory mucosa (Wma) and radiographic assessment will be done. Intraoral antisepsis will be performed with 0.2% chlorhexidine digluconate rinse and an iodine solution will be used to carry out extra oral antisepsis. After administration of local anesthesia, horizontal crestal incision following, mucoperiosteal flaps will be reflected. Care will be taken to preserve as much interproximal soft tissue as possible. Sequential osteotomy will be done and suitable size implant body will be placed with the help of a rachet. The implant body will be covered by cover screw. The mucoperiosteal flaps will be repositioned and secured in place using non-absorbable black silk surgical suture. The interrupted suture will be placed. Surgery will be performed at 2 stages in both site A and O : Stage 1 – implant body will be placed covered by cover screw. Stage 2 – cover screw will be removed and healing abutment will be placed (4 months after stage 1 surgery) 1 month after stage 2 surgery impression will be taken for crown prosthesis and crown will be delivered soon after it is prepared. All implants placement will be done by single trained surgeon at stage 1 and stage 2 surgery. In postoperative care antibiotics Amoxcillin 500mg tid for 5 days and analgesic diclofenac sodium 50mg + paracetamol 500mg tid for 5 days will be prescribed, along with chlorhexidine digluconate rinse twice daily for 2 weeks. Sutures will be removed after 10 days postoperatively. Each patient will be reinstructed for proper oral hygiene measures at each appointment, and re-examined at 6 months and 1 year. Soft and hard tissue evaluation will be performed at 6 months and 1year. Hard tissue evaluation will be done radiographically for the same study. |