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CTRI Number  CTRI/2017/09/009867 [Registered on: 20/09/2017] Trial Registered Retrospectively
Last Modified On: 18/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Socket Augmentation Using Minimally Invasive Approach 
Scientific Title of Study   A Clinical and radiographic study on comparison of microsurgical and macrosurgical technique using bioactive synthetic bone graft and collagen membrane for socket augmentation - A Randomized Controlled Clinical Trail . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepali Jain 
Designation  Senior Resident 
Affiliation  Teerthanker Mahaveer Dental College and research Centre 
Address  Teerthanker Mahaveer University- Campus, Faculty Block - B. Room no. 303,Bagadpur, NH-24, Delhi road, Moradabad

Moradabad
UTTAR PRADESH
244001
India 
Phone  8171992408  
Fax    
Email  drdeepali1026@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RANJANA MOHAN 
Designation  Professor and Head of the Department 
Affiliation  Teerthanker Mahaveer Dental College and research Centre 
Address  Teerthanker Mahaveer University- Campus, Faculty Block - A. Room no. 103,Bagadpur, NH-24, Delhi road, Moradabad

Moradabad
UTTAR PRADESH
244001
India 
Phone  9935038313  
Fax    
Email  ranjanamohan16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepali Jain 
Designation  Senior Resident 
Affiliation  Teerthanker Mahaveer Dental College and research Centre 
Address  Teerthanker Mahaveer University- Campus, Faculty Block - B. Room no. 303,Bagadpur, NH-24, Delhi road, Moradabad

Moradabad
UTTAR PRADESH
244001
India 
Phone  8171992408  
Fax    
Email  drdeepali1026@gmail.com  
 
Source of Monetary or Material Support  
Teerthanker Mahaveer University, Delhi Road, Bagadpur, Moradabad, Uttar Pradesh 244001 
 
Primary Sponsor  
Name  Teethanker Mahaveer University 
Address  Teerthanker Mahaveer University,Bagadpur, NH-24, Delhi road, Moradabad , U.P. 
Type of Sponsor  Research institution and hospital 
 
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 
Deepali Jain  Teethanker Mahaveer University  Department of Periodontology, Room number 2, Ist Floor, Bagadpur, Moradabad
Moradabad
UTTAR PRADESH 
8171992408

drdeepali1026@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Teerthanker Mahaveer University, Moradabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Periodontitis with Mobility that require extraction and in future to be replaced using dental implants.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  MACROSURGICAL TREATED SITES  COMPARATOR - MACROSURGICAL INSTRUMENTS AND SUTURES USING BONE GRAFT AND COLLAGEN MEMBRANE FOR TREATMENT OF SOCKET AUGMENTATION. 
Intervention  MICROSURGICAL TREATED SITES  INTERVENTION -DENTAL OPERATING MICROSCOPE AND MICRO SURGICAL INSTRUMENTS AND SUTURES USING USING BONE GRAFT AND COLLAGEN MEMBRANE FOR TREATMENT OF SOCKET AUGMENTATION 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Sockets of extracted teeth having atleast 7mm residual alveolar bone height as measured clinically and radiographically with intact socket walls.
2 Anterior teeth with grade 3 mobility and having hopeless prognosis
3 No systemic disorders
 
 
ExclusionCriteria 
Details  1 Any systemic diseases where periodontal surgery is contraindicated.
2 History of drug allergy.
3 Pregnant patients.
4 Smoking or tobacco chewing.
5 Presence of periapical pathology
6 Root surface restorations.
7 Root caries that would require restorations.
8 Failure to complete the informed consent.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Crestal height
Mesiobuccal, Mid Buccal, Distobuccal, and Midlingual
Color Doppler Flowmetry ( in PSV)
 
(all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months

 
 
Secondary Outcome  
Outcome  TimePoints 
Crestal height
Mesiobuccal, Mid Buccal, Distobuccal, and Midlingual
Color Doppler Flowmetry ( in PSV)
 
(all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months

 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/08/2015 
Date of Study Completion (India) 26/06/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Aim and Objectives of the study: A Randomized Controlled Clinical study was conducted to evaluate and compare the efficacy of Microsurgical over Macrosurgical technique using Synthetic Nanocrystalline Hydroxyapatite (Sybograf- plus™) and β-tricalcium phosphate Composite bone graft and bioresorbable collagen membranes made of Type – I collagen (Healiguide) TM for socket augmentation

Materials and Methods: A total of 30 extraction sites from 9 patients, aged 30 to 55 years were selected for augmentation of socket immediately after the tooth extraction. Equal number of sites were selected from each patients and randomly divided into Control (Macrosurgical) sites and Test (Microsurgical) sites. The clinical evaluation of Test and Control sites was done at baseline, 3, 6 and 9 months for Mesiobuccal, MidBuccal, Distobuccal and MidLingual/Palatal measurements. Post-operative vascularity was evaluated by Ultrasound Doppler Flowmetry at baseline, 10th Day and 1 month. Radiological assessment was done at baseline, 6 and 9 months for socket height, Buccolingual width at 1/4th , 1/2 and 3/4th  height of  the socket, mesio-distal width of the socket and the bone density recorded at apical, middle and coronal, buccal, palatal, mesial and distal wall of socket on Dentascan in Hounsfield units (HU).

Results: Increase in socket height was observed in Test sockets at 9 months which was statistically significant as compared to Control ones. Test group demonstrated better vascularization as compared to Control group at 10 day and 1 month and all changes are statistically significant in Test group (p<0.05) . Bone formation and density (HU) was found to be significantly higher in Test group (p = .000) as compared to Control group both at 6 months as well as at 9 months.

·         Conclusion: Significant Gain in alveolar bone height was observed at the end of nine months in both Test and Control groups clinically.

·         Ultrasound Doppler Flowmetry revealed superior vascularization of Microsurgically/Test treated sites in initial phase of wound healing than the traditional /Conventional/Control one.

·         Extended surgical time of Microsurgical approach was compensated for faster vascularization with rapid healing of site leading to more predictable gingival contour with improved esthetic outcome than the Control one. Substantial enhancement of immediate postsurgical esthetics of a Microsurgical site to that of Macrosurgical one was demonstrated.

·         Radiographically, sagittal sections confirmed significant increase in the socket height and buccolingual width on CT scan with significant increase in the density of bone in both Test and Control groups.

 

Keywords: Biphasic hydroxyapatite; Collagen membrane; Dentascan; Microsurgical; Socket augmentation; Ultrasound Doppler Flowmetry.

 

 

 
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