biological and radiological evaluation of osseointegration around implants with and without L-PRF.
- Conditions
- Partial loss of teeth,
- Registration Number
- CTRI/2022/03/041087
- Lead Sponsor
- DR NIVYA JOHN
- Brief Summary
Aim:
•To assess the effect of L-PRF on implant stability,crestal bone levels and wound healing of implants in low density bone .
•Primary objectives
•To assess the effect of L-PRF on osseointegration of implants in low density bone.
•To assess the biomarker expression from the samples (Periimplant Crevicular Fluid(Peri implant crevicular fluid) and Saliva) with and with LPRF Treatment
• To estimate the density changes using Cone-Beam Computed Tomography (CBCT) around implants
•Secondary objectives:
1.To evaluate the effect of PRF on clinical parameters related to soft tissue healing, post-surgical pain/inflammation and early complications of mandibular implants in edentulous patients.
2. soft tissues volumetric changes pre and post- surgery using intraoral scans
Preoperative investigations and Preparation:
•A complete blood profiling ,Oral Hygiene Index ,Bleeding on Probing, Pre operative Orthopantomograph will be done for each patient TO ESTABLISH baseline parameters
•Prophylactic pharmacological management will also be done AT THE SURGICAL PHASE.
•Implant selection as per the bone architecture WILL BE DONE
•Sampling Method: Convenient sampling
• Patients will be recruited from the OPD at the Department of Oral Implantology at AB SHETTY MEMORIAL INSITITUTE OF DENTAL SCIENCES,NITTE DEEMED TO BE UNIVERSITY.,MANGALORE
•Based on the observations from previous literature ,the following sample size estimation is done.1
•η=(z/2 + zβ) σ2
•(μ-μ0)2
•
•n=(1.96+0.84)2 \*(15.22)2/(17.81-7.82)2
•
•18.16 samples per group
•Considering loss to follow up of 10%, 20 samples per group
•Study group(LPRF Rx)=20 samples
•Control group= 2o sample
•Each patient will have one edentulous area on each quadrant of the U/L Jaw.
Implant installation & Site Randomisation :
•At the time of surgery, randomization codes (+ for intervention) will be generated using the randomization software (sealed envelopeTM). The site will be selected as per slot.The side with (plus) code will receive LPRF application .
•Only one of the site per patient will be selected for the intervention.
Surgical phase:
• Each patient will be administered 1 gram of amoxicillin before surgery. Local anaesthesia will be achieved bilaterally by infiltrating lignocaine 2% containing 1:80000 adrenaline.
•The implant site preparation will be performed in a similar manner for the two edentulous sites. A full thickness flap reflection, osteotomy site will be prepared as per manufacturers instructions, implants (Straumann, Bone Level , or Tissue level,Basel, Switzerland) will be placed bilaterally depending on the case selection
Liquid Platelet Concentrate and Exudate Preparation:
•10cc of blood will be will be collected to obtain the L-PRF. The centrifuge (Duo Quattro) is equipped with pre programmed operational panel for the centrifugation of blood.
•Thus L PRF (2300 rpm for 12mins) will be obtained as per manufacturers recommendations .
Application of the PRF products:
•After the preparation of the osteotomy site, All the implants will be placed at a minimum insertion torque of 25 Ncm assessed by the physio-dispensor.
•L PRF will be removed from test tube, using sterile tweezers and will be inserted on the implant bed and implant will be coated with LPRF and then placed on edentulous side selected. The contralateral site will be placed with an implant with the similar design without the application of LPRF.
Post operative evaluation and follow up:
•An immediate post operative OPG will be recorded .
•The patient will on therapeutic dose of antibiotics and analgesic until the day of suture removal.
• Patient will be advised to use local antibacterial mouthwashes.
Biomarker study at 0,6,12 months
Procedure:
•The gingiva will be dried by air and cotton pellets for 1 min before sampling and the area will be isolated using cotton rolls.A paper strip of standard length and height (Periopaper, Pro Flow, Amityville, NY, USA) will be inserted into the peri-implant sulcus will be left in place for 30 seconds. Strips macroscopically contaminated with blood or saliva will be discarded. The sample strip will be inserted into plastic sealable Eppendorf tubes and eluated in 100 microlitre of sterile NaCl.
•Following 10 s of vortexing, eluates will be centrifuged and the strips will be removed. The samples will be stored at -80 degree C.
•Enzyme-linked immunosorbent assay (ELISA) for Proinflammatory cytokine (IL-1b and TNF-a) and chemokine (IL-8 and MIP1a) concentrations in Peri implant crevicular fluid eluates will be assessed using commercially available ELISA kits (R&D, SAD)
•Quantokine Immunoasay for Human IL-1 beta (cat. number DLB50), Human TNF-alpha (cat. number DTA50), Human IL-8 (cat. number D800C), Human MIP-1 alpha (cat. number DMA00).
• MMP8 MARKER will be evaluated for evalauation of bone turnover rate.
Osseointegration Speed Index:
•The Implant Stability Quotient values will be measured at the time of implant placement (to check the stability of the implants)
•3 months and 6 month post operatively (Ostell ISQ)
•
•Radiological assessment:
•The quantity of initial bone present will be measured in OPG
•A Cone Beam Computed Tomography (CBCT) will be taken 6 months and 12 months after implant placement.
•The measuring tool in the software will be used to measure the crestal bone levels.
• Also the Hounsfield units will be measured adjacent to the first two and last two implant threads. (density levels)The Planmeca Romexis® software version 3.1 will be used to evaluate the CBCT scan
1.The normality of the data will be assessed using Kolmogorov Smirnov’s Test and Shapiro Wilk’s Test.
2.Continuous variables will be measured in terms of mean and standard deviation for normally distributed data and median and Interquartile Range for non-normally distributed data.
3.Chi squared test will be used to assess discreate variables and will be expressed in terms
4.For normally distributed data, unpaired t test will be used and for non-normally distributed data Mann-Whitney U test will be used.
5.Repeated measured ANOVA will be used to determine the biomarker expression at different time intervals.
6.P value less than 0.05 will be fixed to determine the statistically significant difference.
7.Statistical Analysis will be done using SPSS Software (SPSS Version 22, IBM,Chicago, IL, USA)
•
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
- Inclusion Criteria: Patient requiring implant treatment bilaterally in the maxillary and mandibular arch(D3 ,D4 BONE) Patients with bilateral edentulous with presence of a tooth on either side of edentulous space Patients at least 20 years old, providing consent for documentation and public presentation of their clinical data.
- Patients with fair Oral health Index.
Patients with uncontrolled diabetes, recent cardiac surgery,patients on bisphophanates Patients with bleeding disorders serum glycated haemoglobin ≥ 7.0, prescription of antiâ€inflammatory medications, or antibiotics within the preceding 3 months, Patient with poor oral hygiene index scores(<4) the use of medications known to have an impact on gingival growth.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improved Osseointegration in LPRF sites. baseline: preoperative investigation | 8 weeks: post op investigation | 12 months : post cementation investigation
- Secondary Outcome Measures
Name Time Method clinical evaluation :BLEEDING ON PROBING ,SULCULAR DEPTH BIOMARKER ANALYSIS:PRESENTATION OF INFALMMATORY MARKERS
Trial Locations
- Locations (1)
AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES
🇮🇳Kannada, KARNATAKA, India
AB SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES🇮🇳Kannada, KARNATAKA, IndiaDr Nivya JohnPrincipal investigator9742024358nivyajohn@nitte.edu.in