| CTRI Number |
CTRI/2019/03/018203 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
29/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of bone formation in defects around dental implants simulating artificial roots made up of titanium used to be replacement of missing teeth |
|
Scientific Title of Study
|
Horizontal Bone Augmentation Using Two Membranes At Dehisced Implat Sites:A Randomised Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakhshinda Nahid |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences, IMS, BHU |
| Address |
Unit Of Periodontics
Faculty Of Dental Sciences, IMS,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7390842121 |
| Fax |
|
| Email |
rakhshindanahidbhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Bansal |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, IMS, BHU |
| Address |
Unit Of Periodontics,
Faculty Of Dental Sciences, IMS,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9335499117 |
| Fax |
|
| Email |
drmonika97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakhshinda Nahid |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences, IMS, BHU |
| Address |
Unit Of Periodontics,
Faculty Of Dental Sciences, IMS,
BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7390842121 |
| Fax |
|
| Email |
rakhshindanahidbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rakhshinda Nahid
Unit of Periodontics, Faculty of Dental Sciences, IMS, BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Rakhshinda Nahid |
| Address |
Faculty of Dental Sciences,IMS, BHU |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rakhshinda Nahid |
Faculty of Dental Sciences, IMS, BHU, Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RAKHSHINDA NAHID |
Faculty of Dental Sciences, IMS, BHU |
Room no. 5, Unit of Periodontics,
Varanasi
UTTAR PRADESH |
7390842121
rakhshindanahidbhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee, Institute of Medical Science, BHU, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Single Edentulous Areas Due To Loss Of Tooth
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Collagen group |
Collagen group belongs to the group of resorbable membranes which offer the advantage of being resorbed by the body. |
| Intervention |
Titanium mesh group |
Titanium mesh belongs to the group of non-resorbable membranes. it has high strength and rigidity thus it maintains the space required for bone regeneration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Signed informed consent
Systemically healthy subject
Who will be able to comply with all the procedures
Periodontally healthy patient with probing depth less than or equal to 3mm
Healed extraction sites more than 6 weeks and free of infection
Presence of single edentulous area in maxilla or mandible with buccal alveolar bone deficiency
Dehisence type of defect during implant placement
Initial implant Stability
Stable and favorable occlusal relationship, natural tooth adjacent to the implant site |
|
| ExclusionCriteria |
| Details |
smokers and tobacco users
Acute oral Diseases
Parafunctional habits
Traumatic occlusion
Pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vertical defect height on facial aspect
|
at the time of surgery and at 6 months during re-entry surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Defect width,
Soft tissue dehiscence,
Membrane exposure,
Redness,
Width of keratinized tissue on facial aspect of adjacent teeth.
probing pocket depth of adjacent teeth
swelling
|
Defect width will be evaluated at the time of surgery and at 6 months re-entry,
Width of keratinized tissue and probing pocket depth will be evaluated at the time of initial examination, surgery, 4th week, 3rd months and 6th months.
Soft tissue dehiscence, membrane exposure, redness and swelling will be evaluated at the time of 1st week, 4th weeks, 3rd months and 6th months after initial surgery.
|
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
20/03/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A minimum bucco-lingual ridge width of 6 mm is required for a 4 mm implant, allowing at least 1 mm of bone to remain buccally and lingually after implant insertion. If the remaining facial or lingual bone is less than 1 mm, there is an increased risk of bone dehiscence or fenestration during surgery. In present study, the defect on the facial side of implant during surgery will be managed with the help of bone grafts and placement of collagen or titanium mesh membrane. After 6 months, the effect of membrane on bone augmentation will be evaluated. |