| CTRI Number |
CTRI/2024/05/067479 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Clinical Study Comparing Xenograft Against Demineralized Freeze-Dried Bone Allograft (DFDBA) in Ridge Preservation for Maxillary Anterior Sites, followed by Implant Placement. |
|
Scientific Title of Study
|
Ridge Preservation in Maxillary Anterior Sites Comparing Xenograft Versus Indigenously Prepared Demineralized Freeze-Dried Bone Graft (DFDBA) With Subsequent Implant Placement: A Randomized Clinical 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 Jwngmashri Basumatary |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Mirdard Marg, Bahadur Shah Zafar Marg,Delhi.
Central
DELHI
110002
India |
| Phone |
7636042995 |
| Fax |
|
| Email |
jwngma1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Tandon |
| Designation |
Professor |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Mirdard Marg, Bahadur Shah Zafar Marg, Delhi.
Central
DELHI
110002
India |
| Phone |
9654700982 |
| Fax |
|
| Email |
tandonshruti16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jwngmashri Basumatary |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Mirdard Marg, Bahadur Shah Zafar Marg, Delhi.
Central
DELHI
110002
India |
| Phone |
7636042995 |
| Fax |
|
| Email |
jwngma1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Jwngmashri Basumatary |
| Address |
Mirdard Marg, Bahadur Shah Zafar Marg, LNJP Colony, New Delhi, Delhi,110002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jwngmashri Basumatary |
Maulana Azad Institute of Dental Sciences |
6th floor, Department of Periodontology, Room No. 603, Mirdard Marg, Bahadur Shah Zafar Marg, LNJP Colony.
Central
DELHI |
7636042995
jwngma1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Institute of Dental Sciences, New Delhi(Govt. of NCT of Delhi) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K083||Retained dental root, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Demineralized Freeze Dried Bone Allograft. |
Demineralized Freeze Dried Bone Allograft will be utilized in particle form within the extracted socket only once after the extraction of the tooth, with the quantity of graft adjusted according to the size of the socket. Subsequently the implant will be placed after 6 months of the placement of the graft. |
| Comparator Agent |
Xenograft |
Xenograft will be utilized in particle form within the extracted socket with quantity of the graft according to the socket size but not less than 0.25cc only once after the extraction of the tooth. Subsequently the implant will be placed after 6 months of the placement of the graft. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either sex between the age group of 18-16 years, who sign informed consent form for the study.
2. Subjects in whom extraction is indicated in at least one single rooted tooth in anterior maxilla.
3. Clinical root length should be equal to or greater than 8mm.
4. The presence of more than 50% of the buccal bone height.
5.Subjects who is compliant to maintain oral hygiene instructions
6. To select only sites where the tooth location and root angulation is consistent with the ideal implant orientation, where interocclusal distance is adequate for a dental implant placement.
7. Non-smokers.
|
|
| ExclusionCriteria |
| Details |
1. Teeth adjacent to the concerned tooth should not have any periapical or active periodontal disease.
2. Pregnant women or expected pregnancy during the study period.
3. Lactating women.
4. Subjects with bone disease (Paget disease, Rickets, Osteoporosis, Multiple Myeloma etc.) and Radiographic evidence of bone tumour (benign/malignant) or cyst.
5. Subjects under long-term bisphosphonate therapy.
6. Subjects with uncontrolled systemic diseases taking immunosuppressive/ anticoagulant medications.
7. Any medical condition that contraindicates surgery.
8. Any known history of allergy to medications and graft materials used in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in the bucco-palatal width of the alveolar ridge.
2. Changes in the vertical height of the alveolar ridge.
3. Changes in soft tissue (width and thickness of keratinised gingiva). |
1. Baseline
2. 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the clinical adverse effects of the grafts, if any.
2.Changes in clinical attachment level (CAL) at teeth adjacent to the extraction site |
1. Baseline
2. 6months |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
30/05/2024 |
| 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="2"
Months="0"
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
|
This study focuses on preserving edentulous ridge, which are best treated with implants due to their need for substantial bone support. The aim is to use Xenograft or Demineralized Freeze- Dried Bone Allograft to graft the socket and preserve the ridge. Additionally, the study seeks to compare the effectiveness of these graft materials in preserving the ridge efficiently. |