FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/051162 [Registered on: 29/03/2023] Trial Registered Prospectively
Last Modified On: 28/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Augmentation of horizontally deficient ridges using combination Fence technique and platelet rich fibrin block 
Scientific Title of Study   Horizontal ridge augmentation using Fence technique in combination with PRF block- A clinico-radiographic study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megha HR 
Designation  Post graduate student 
Affiliation  Bapuji Dental College and Hospital 
Address  Dr.Megha HR Room no.5,first floor, Dept. of Periodontics, Bapuji Dental College and hospital,Davangere,Karnataka,
D/o Ravikumar HK Arabilachi post Bhadravathi taluk Shimoga
Shimoga
KARNATAKA
577004
India 
Phone  9148357608  
Fax    
Email  hulumanderi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tarun Kumar AB 
Designation  Professor 
Affiliation  Bapuji Dental College and Hospital 
Address  Dr.Tarun Kumar Room no.5,first floor, Dept. of Periodontics, Bapuji Dental College and hospital,Davangere,Karnataka,

Davanagere
KARNATAKA
577004
India 
Phone  9886210507  
Fax    
Email  tarundental@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megha HR 
Designation  Post graduate student 
Affiliation  Bapuji Dental College and Hospital 
Address  Dr.Megha HR Room no.5,first floor, Dept. of Periodontics, Bapuji Dental College and hospital,Davangere,Karnataka,
D/o Ravikumar HK Arabilachi post Bhadravathi taluk Shimoga
Shimoga
KARNATAKA
577004
India 
Phone  9148357608  
Fax    
Email  hulumanderi@gmail.com  
 
Source of Monetary or Material Support  
DR.Megha HR Dept of Periodntics,Room no.5, Bapuji Dental College and hospital,Davangere,Karnataka 
 
Primary Sponsor  
Name  DrMegha HR 
Address  Room no.5, First floor Dept of periodontics Bapuji dental college and hospital,Davangere 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMegha HR  Bapuji Dental college and hospital  Department of Periodontics,Room no.5,Bapuji dental college and hospital,MCC b block,Davanagere
Davanagere
KARNATAKA 		 9148357608

hulumanderi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board,Bapuji dentalcollege and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K063||Horizontal alveolar bone loss,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fence technique in combination with PRF block  Surgical Procedure: Preparation of recipient site: Administration of local anesthesia (2% lignocaine with adrenaline1:80000). An incision will be positioned slightly on the palatal/lingual crest of the edentulous ridge using a vestibular bevel. A full thickness flap will be raised buccally to expose the area to be augmented. Adaptation of titanium plates: The titanium osteosynthesis plate used during surgery will be positioned at the planned distance from the native bone in order to create a physical barrier (“fence”) that contain necessary bone graft, permitting horizontal augmentation. The plate will be fixed using titanium miniscrews. Bone is harvested from the area adjacent to surgical site using a bone scraper.13 Intravenous blood will be collected through a venipuncture of the median cubital vein in the antecubital fossa into suitable PRF tubes of 9mL each. Preparation of A-PRF: Blood in red cap tube will be used to make A-PRF by centrifugation at 1300 rpm for 8 minutes. Preparation of i-PRF: Blood in orange cap tube will be used to make i-PRF by centrifugation at 700rpm for 3 minutes. Preparation of PRF block: A-PRF obtained from red cap tube will be compressed in PRF box to achieve a membrane. It will then be cut into pieces and mixed with xenograft bone particles (particle size:0.5 – 1mm).and autogenous bone. To this, i – PRF liquid is added and mixed to obtain PRF block. PRF block will be placed to fill the space between the bone wall and the internal surface of the titanium plate. A collagen membrane will be sutured into palatal aspect and reflected onto the vestibular aspect, sutured into the buccal aspect to obtain a perfect seal. Flaps will be approximated and sutures will be placed for closure of flap margins. POST-SURGICAL INSTRUCTIONS: Patients will be kept on an antibiotic coverage for 6 days and analgesic as required. Patients will be instructed to rinse mouth using mouthwash (0.2% chlorhexidine twice daily for 15 days). Patient will be asked to avoid brushing in the surgical site for 2 weeks and also will be prohibited to chew food. Patients will be asked to apply the ice pack in the operated area for 1st few hours intermittently. Patient will be instructed to report back to the department after 10 days for suture removal. Clinical parameters: Clinical measurement of ridge width will be examined at 3 sites i.e. mesial 3rd, mid 3rd and distal 3rd at crest of edentulous ridge using UNC-15 periodontal probe at baseline and after 4 months of surgery. Radiographic parameters: Cone beam Tomographs (CBCT) will be taken and assessed at baseline and after 4 months at crest, 3mm below crest and 6mm below crest to quantify the difference in ridge width.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Healthy patients with Seibert Class I horizontally deficient ridge requiring dental implants
 
 
ExclusionCriteria 
Details  smokers,alcoholics, patients and anti platelet therapy,
pregnant,lactating women
patients on bisphosphonate therapy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare clinically ridge width between baseline and 4 months after augmentation using ‘Fence Technique’ in Seibert’s class I horizontally deficient ridge.  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare radiographically ridge width between baseline and 4 months after augmentation using ‘Fence Technique’ in Seibert’s class I horizontally deficient ridge.  4 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 2/ Phase 3 
Date of First Enrollment (India)   14/04/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
Brief Summary  

BACKGROUND

Tooth extraction is followed by a reduction of the dimension of the alveolar ridge leading to alteration in host bone available for placement of implant. Procedure like bone augmentation have enabled the placement of implants in edentulous ridges lacking sufficient amount of bone for standard implant placement. Horizontal bone defects can be treated by various techniques, such as guided bone regeneration, onlay bone grafting, or split crest procedures (edentulous ridge expansion). Recently, a new surgical procedure, the “fence technique”, was developed. This technique has the advantage to plan in advance the volume of the bone augmentation by creating space using osteosynthesis plates for grafting biomaterial and stabilization of collagen membrane. PRF block is a novel bioactive bone block made using Solid-PRF fragments, Liquid-PRF and bone graft which consists of fibrin mesh which holds particulate bone graft material in a network and prevents scattering of graft material. PRF block acts as matrix consisting various biomolecules and growth factors which help in bone healing and regeneration. Hence the aim of this study is to evaluate the efficiency of ‘Fence Technique’ with PRF block in augmentation of horizontally deficient ridges.

METHODOLOGY

In this prospective clinic radiographic study, a total of 10 patients with 29 edentulous sites having of horizontally deficient ridge defects (Seibert Class I, <3mm) will be included. Following the assessment of pre-operative CBCT scans, 3-D stereolithographic models will be obtained. Titanium osteosynthesis plates will be  moulded on those STL models. All subjects will be treated using Fence Technique in combination with PRF block which will be stabilized using titanium osteosynthesis screws. The clinical ridge width will be measured at mesial, middle and distal aspect of the edentulous at baseline and 4 months. The radiographic ridge width will be measured using CBCT at crest, 3mm below crest and 6mm below crest at baseline and 4 months postoperatively.

CONCLUSION

Within the limitations of the study, it could be concluded that combination of Fence Technique and PRF Block will be a successful and predictable approach for augmentation of horizontally deficient edentulous ridges.

KEY WORDS:

Fence technique; platelet rich fibrin; platelet rich fibrin block; ridge augmentation; titanium osteosynthesis plates; titanium screws.

 

 

 
Close