| CTRI Number |
CTRI/2023/05/052557 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
extracted tooth socket preservation using allograft and probiotic with collagen membrane |
|
Scientific Title of Study
|
Comparative evaluation of socket preservation in anterior teeth using Allograft Vs Probiotic and collagen membrane -A Cone Beam Computed Tomography Analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Rekha rani |
| Designation |
professor and H.O.D |
| Affiliation |
Panineeya Institute of Dental Sciences and Research centre. |
| Address |
Panineeya Institute of Dental Sciences and Research centre
Department of periodontics Room no 101 road no 5 kamalanagar
Dilsuknagar Hyderabad
Hyderabad
TELANGANA
500060
India
Hyderabad
TELANGANA
500060
India |
| Phone |
04024141177 |
| Fax |
04024045037 |
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rekha rani |
| Designation |
professor and H.O.D |
| Affiliation |
Panineeya Institute of Dental Sciences and Research centre. |
| Address |
Panineeya Institute of Dental Sciences and Research centre
Department of periodontics Room no 101 road no 5 kamalanagar
Dilsuknagar Hyderabad
Hyderabad
TELANGANA
500060
India
Hyderabad
TELANGANA
500060
India |
| Phone |
04024141177 |
| Fax |
04024045037 |
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHILUVERU SNEHA |
| Designation |
Post graduate |
| Affiliation |
Panineeya Institute of Dental Sciences and Research centre. |
| Address |
Panineeya Institute of Dental Sciences and Research centre
Department of periodontics Room no 101 road no 5
kamalanagar
Dilsuknagar Hyderabad
Hyderabad
TELANGANA
500060
India
Hyderabad
TELANGANA
500060
India |
| Phone |
9052595566 |
| Fax |
04024045037 |
| Email |
sharu.sneha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Institute of dental sciences
room no 101,road no 5 kamalanagar,dilshuknagar |
|
|
Primary Sponsor
|
| Name |
Panineeya Institute of dental sciences |
| Address |
Panineeya Institute of dental sciences and research centre room no 101 road no 5 Panineeya Institute of dental sciences
kamalanagar
Dilshuknagar Hyderabad Telangana 500060 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Panineeya Institute of dental sciences |
Panineeya Institute of dental sciences
kamalanagar
Dilshuknagar Hyderabad Telangana 500060 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rekha rani |
panineeya dental college and reserch center |
department of periodontics
room no 101, road no.5, kamala nagar, Dilsukhnagar.
Hyderabad
TELANGANA |
9885160094
04024045037
rekhasarat2304@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
group 1 10 patients
|
socket preservation after extraction using Allograft with collagen membrane
cbct taken at baseline and 3 months |
| Comparator Agent |
Group 2 10 patients |
socket preservation after extraction using probiotic and collagen membrane
cbct taken at baseline and 3 months
|
| Intervention |
group 3 10 patients |
socket preservation using combination of allograft and proboitic with collagen membrane
cbct taken at baseline and 3 months
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Extraction of Maxillary or mandibular non restorable single rooted teeth.
Presence of teeth adjacent to extracted socket
|
|
| ExclusionCriteria |
| Details |
Participants who are smokers
Pregnant and lactating woman.
Patients having motor difficulties that impede or hamper hygiene
Immunocompromised individuals and patients with metabolic bone diseases or who have undergone radiotherapy in the last five years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the healing of extracted socket will be evaluated
|
baseline,one week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Which monotherapy will be more effective allograft or probiotic in the healing of extracted socket Will combination therapy allograft plus probioticbe more benificial in the healing of extracted socket
|
baseline,three months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/05/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SOCKET PRESERVATION: Socket preservation or alveolar ridge preservation is a procedure to reduce bone loss after tooth extraction After tooth extraction, the jaw bone has a natural tendency to become narrow, and lose its original shape because the bone quickly resorbs, resulting in 30–60% loss in bone volume in the first six months. Bone loss, can compromise the ability to replace the tooth or its aesthetic and functional ability. |
Demineralized freeze-dried bone allograft (DFDBA) Is a graft composed of demineralized bone matrix It is effective in the reconstruction of bone defects and has also demonstrated osteo inductive properties. When implanted in bone that is already well-vascularized, it has the ability to stimulate cell attachment, cell migration, and osteogenesis. It causes new bone formation to take place during healing and is a commonly used material for bone enhancement and bone development processes. Probiotics are used to help in the recolonization of beneficial bacteria as well as to modulate the immune response. They have been stated to help in wound healing also. They are available in the form of gels, lozenges, tablets and chewing gum. | |