| CTRI Number |
CTRI/2025/01/078937 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Clinical and radiographic evaluation of vertical ridge augmentation for future placement of dental implant |
|
Scientific Title of Study
|
Clinical and radiographic assessment of guided bone regeneration using combination of autogenous and xenogenic bone graft with titanium reinforced dense polytetrafluoroethylene membrane (TR-d-PTFE) in vertical ridge augmentation- A prospective study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Reshama Bansal |
| Designation |
PG Student |
| Affiliation |
Govt. college of dentistry, Indore |
| Address |
Room no. 10, Department of Periodontology, Govt. college of dentistry, indore, opposite MY hospital Sardar patel marg
Indore
MADHYA PRADESH
452001
India |
| Phone |
8965940388 |
| Fax |
|
| Email |
r8871243070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shaleen Khetarpal |
| Designation |
Associate Professor |
| Affiliation |
Govt. college of dentistry, Indore |
| Address |
Room no. 10, Department of Periodontology, Govt. college of dentistry, indore, opposite MY hospital Sardar patel marg
Indore
MADHYA PRADESH
452001
India |
| Phone |
9827529603 |
| Fax |
|
| Email |
drshaleenk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Reshama Bansal |
| Designation |
PG Student |
| Affiliation |
Govt. college of dentistry, Indore |
| Address |
Room no. 10, Department of Periodontology, Govt. college of dentistry, indore, opposite MY hospital Sardar patel marg
Indore
MADHYA PRADESH
452001
India |
| Phone |
8965940388 |
| Fax |
|
| Email |
r8871243070@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 10, Department of Periodontology, Govt. college of dentistry, indore, opposite MY hospital Sardar patel marg , Indore, India, Pin code 452001 |
|
|
Primary Sponsor
|
| Name |
Govt college of dentistry Indore |
| Address |
Room no. 10, Department of Periodontology, Govt. college of dentistry, indore, opposite MY hospital Sardar patel marg , Indore, Madhya Pradesh, India, Pin code 452001 |
| Type of Sponsor |
Government medical college |
|
|
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 Reshama Bansal |
Govt. college of dentistry, Indore |
Room no. 10, Department of Periodontology, opposite MY hospital Sardar patel marg
Indore
MADHYA PRADESH |
8965940388
r8871243070@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government College of Dentistry,Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
VERTICAL ALVEOLAR RIDGE AUGMENTATION IN EDENTULOUS SITE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
vertical alveolar ridge augmentation |
To Evaluate the amount of bone gain after vertical ridge augmentation by guided bone regeneration using autogenous and xenogenic bone graft covered with non resorbable titanium reinforced dense polytetrafluoroethylene membrane at TO- Base line value, at T1- immediately post op T2- 6 month after post operative |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with single or multiple missing maxillary or mandibular teeth, either unilaterally or bilaterally with upto 5mm of ridge height deficiency.
2.20-50 years of age of both sex and able to sign an informed consent.
3.Maintainable oral hygiene.
4.Who will be ready to have their progress followed for at least 6 months.
|
|
| ExclusionCriteria |
| Details |
1.Patients requiring more than 5mm of vertical ridge augmentation.
2.Patients with systemic illness/systemic drugs that would affect postoperative healing.
3.Patients with poor oral hygiene
4.Chronic smokers,
 Pregnancy or lactation
 Psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the vertical alveolar ridge height gain |
T0- at base line value
T1- Immediately post operative
T2- 6 month post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the pain & swelling post operatively |
T1-1 day post operative
T2-3 day post operative
T3-5 day post operative
T4-7 day post operative |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2025 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 05-03-2024 and end date provided 05-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Assessment of vertical alveolar ridge height gain after guided bone regeneration procedure using autogenous bone and xenograft partcles which covered by non resorbable membrane |