| CTRI Number |
CTRI/2025/02/081005 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate and compare the bone density and peri implant tissues in implants placed in maxillary anterior segment using osseodensification with and without L-PRF: a randomized control trial |
|
Scientific Title of Study
|
Comparative evaluation of bone density and peri implant tissues in implants placed in maxillary anterior segment using osseodensification with and without L-PRF: A randomized control 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 Saurabh Loya |
| Designation |
PG Students |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Department of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8669744240 |
| Fax |
|
| Email |
drsaurabhloya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Head of the department professor guide and dean |
| Affiliation |
Ranjee Deshmukh Dental College and Research Centre |
| Address |
Department Of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Head of the department professor guide and dean |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Department Of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills Hingna Nagpur-440019,Mahrashtra ,India |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
104 Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna road Nagpur- 440019,India |
| Type of Sponsor |
Other [Ranjeet Deshmukh Dental college and Research Centre Digdoh Hills Hingna Road Nagpur- 440019 India] |
|
|
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 Abhay Kolte |
Ranjeet Deshmukh Dental College and Research Centre |
104 Department Of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road,
Nagpur 440019
Nagpur
MAHARASHTRA |
09011071467
drabhaypkolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
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, (2) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant placement in maxillary anterior segment using osseodensification |
In Group I (Control group) implant placement in maxillary anterior segment using osseodensification alone |
| Comparator Agent |
L-PRF |
In Group II (Test group) implant placement in maxillary anterior segment using osseodensification with L-PRF. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Patients having partially edentulous spaces in maxillary anterior segment.
Patient with healthy and stable soft tissue architecture
Co-operative, motivated and hygiene conscious patients.
Patient aged above 18 years.
Patients who gave written consent for the procedure.
|
|
| ExclusionCriteria |
| Details |
General contraindications to implant surgery.
Patients with a history of irradiation in the head and neck area, within the last 6 months.
Patients under treatment with drugs which significantly impact periodontal inflammation and bone turnover
Smokers or patients with poor oral hygiene.
Patients with severe clenching and grinding
Pregnant or lactating females.
General bone or Blood disorders
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The aim of the present study is to evaluate and compare bone density and peri implant tissues in implants placed in partially edentulous maxillary anteror segment using osseodensification with and without L-PRF: A clinical and radiographic study.
|
Baseline 3 months 6 months and 9 months post operatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare crestal bone height, implant stability, buccal bone thickness, ridge width and vertical distance in patients with dental implants placed in partially edentulous maxillary anterior segment using osseodensification with and without L-PRF, at baseline and 9 months post surgery using CBCT
To evaluate and compare modified plaque index, sulcular bleeding index, implant sulcus depth, gingival thickness and ridge width in patients with dental implants placed in partially edentulous maxillary anterior segment using osseodensification with and without L-PRF |
BASELINE , 3 , 6 & 9 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
05/03/2025 |
| 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 randomized controlled trial will be conducted to evaluate bone density and peri implant tissues in implants placed in patients with partially edentulous maxillary anterior segment using osseodensification with and without L-PRF Total 42 sites will be included in the study which will be divided into following groups: Group I (Control group): 21 sites for implant placement in maxillary anterior segment using osseodensification alone. Group II (Test group):21 sites for implant placement in maxillary anterior segment using osseodensification with L-PRF. All patients will go thorough clinical evaluations, and case histories will be recorded.Cone-beam computed tomography (CBCT) will be performed prior to the surgery to evaluate the quantity and quality of bone as well as to mark the important anatomical landmarks. Additionally, complete blood analyses, including, estimations of blood glucose levels, bleeding and clotting times, and viral screening for HIV, hepatitis B virus, and hepatitis C virus will be carried out. L-PRF will be prepared according to the protocol. Crestal and sulcular incisions will be perfomed and a full-thickness mucoperiosteal flap will be raised and reflected. The osteotomy site will be prepared using densah drills in sequential order. In Group I (Control group) implant placement in maxillary anterior segment using osseodensification alone. In Group II (Test group) implant placement in maxillary anterior segment using osseodensification with L-PRF. The flap will be sutured with 3-0 nonabsorable silk suture. Standard postoperative instructions will be given, along with antibiotics and analgesics. Suture removal will be done at 7th day. Follow-up visits will be scheduled at 3 and 9 months, postoperatively. The following clinical parameters will be evaluated: 1. Mombelli’s modified Plaque index (mPI), 2. Mombelli’s modified sulcular bleeding index (mSBI) 3. Implant sulcus depth – will be measured using periodontol implant probe. 4. Ridge width measurement- It will be done using Bone Gauge at 2mm and 4mm from alveolar crest. 5. Gingival thickness- will be done using endodontic spreader with rubber stopper. 6. Implant Stability will be evaluated with surgical rachet at the time of implant insertion. Following radiographic parameters will be evaluated using CBCT at baseline and 9 months. 1. Bone density (BD)– Assessment of bone density will be done on Image J software. 2. Crestal bone height (CBH) 3. Buccal bone thickness (BT)- At the crest, 5mm from crest and 10 mm from crest will be assessed using CBCT. 4. Ridge width (RW) – Bucco-lingual dimension of osseous ridge will be assessed. 5. Vertical distance (VD) between 1st radiographic bone implant contact and 1st implant thread on mesial and distal sides and amount of bone loss on mesial and distal side. Buccal and Palatal gingival thickness measurement will also be done. | |