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
|
|
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
|
|
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- plusâ„¢) 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.
|