| CTRI Number |
CTRI/2023/08/056265 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Modification of narrow ridges for implant placement |
|
Scientific Title of Study
|
Horizontal augmentation of jaw bone by ridge split and expansion for implant placement in atrophic sites |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GOKILA VANI S U |
| Designation |
Academic junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9976328104 |
| Fax |
|
| Email |
drgokila22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Bansal |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9335499117 |
| Fax |
|
| Email |
drmonika97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GOKILA VANI S U |
| Designation |
Academic junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9976328104 |
| Fax |
|
| Email |
drgokila22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Eminence, BHU and Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
GOKILA VANI S U |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi-221005 |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 |
| Dr GOKILA VANI S U |
Faculty of Dental Sciences, IMS, BHU |
Room no.5, Division of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi-221005
Varanasi
UTTAR PRADESH |
9976328104
drgokila22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Banaras Hindu University, IMS, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implants placed after ridge splitting and expansion in sites with moderate ridge deficiency having (4-6) mm horizontal bone width |
The bone splitting and expansion technique will be performed using piezoelectric system and screw expanders and implants will be placed. Ridge width before and after ridge expansion will be measured at 2mm and 6mm from the alveolar crest using surgical caliper and acrylic stent. Implant stability quotient and torque will be evaluated |
| Intervention |
Implants placed after ridge splitting and expansion in sites with severe ridge deficiency having (3-4) mm horizontal bone width |
The bone splitting and expansion technique will be performed using piezoelectric system and screw expanders and implants will be placed. Ridge width before and after ridge expansion will be measured at 2mm and 6mm from the alveolar crest using surgical caliper and acrylic stent. Implant stability quotient and torque will be evaluated |
| Comparator Agent |
Implants placed using conventional drilling technique in sites with mild ridge deficiency having (6-8)mm horizontal bone width |
Implants will be placed and alveolar ridge width will be measured with the help of surgical caliper and acrylic stent having markings at 2mm and 6mm from the alveolar crest. Implant stability quotient and torque will be evaluated |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Physically and mentally healthy patient
-Patients who will be willing and able to comply with the study related procedures.
-Periodontally healthy patient with periodontal probing depth ≤ 3mm and good oral hygiene.
-Patient having favourable and stable occlusal relationship and natural roots adjacent to the implant site.
-Edentulous sites in maxilla and mandible must be free from infection.
-At least 1-3 teeth missing.
-Having a crestal width of atleast 3mm and an 8mm apico-coronal height from major anatomical structures.
|
|
| ExclusionCriteria |
| Details |
-History of smoking, chewing tobacco, drug or alcohol abuse, para functional habits.
-History of radiotherapy in the head and neck region for malignancies, bisphosphonate therapy.
-Systemically unhealthy subjects.
-Subjects with acute oral and gingival diseases.
-Pregnancy and lactating mothers.
-Subjects with a history of allergy.
-Unwillingness to sign consent form and review for all follow-up periods.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Alveolar ridge width measurement in all three groups
2.Implant stability quotient
3.Torque |
1. For alveolar ridge width, the timepoints are, before & after implant placement in comparator group and before (Pre-op) and after (post-op) ridge expansion in intervention groups
2. For implant stability quotient, the time points are at the time of implant placement, 3rd month, 6th month
3.For torque, the time point is at the time of implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain
|
1.For pain, the timepoints are at the time of surgery,1st week, 2nd week, 4th week after surgery
|
| 2. Redness & swelling |
2.For redness & swelling, the time points are 1st week, 2nd week,4th week after surgery
|
| 3. Soft tissue thickness |
3.For soft tissue thickness, the time points are at the time of surgery, 4th week, 3rd month, 6th month after surgery
|
| 4. IL-1β & TNFα (if feasible) |
4.For IL-1β & TNFα, the timepoints are before prothesis & 2 weeks after prothesis( if feasible) |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
16/08/2023 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sufficient alveolar ridge is essential for implant Rehabilitation in atrophic edentulous sites. Ridge splitting and expansion is one of the various methods of horizontal ridge augmentation. It enables simultaneous implant placement, eliminates the need for bone harvesting and reduces the risk of graft or membrane exposure. Therefore , the overall treatment time is shortened and morbidity is reduced. |