| CTRI Number |
CTRI/2019/06/019723 [Registered on: 18/06/2019] Trial Registered Prospectively |
| Last Modified On: |
15/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Soft and Hard Tissue Changes Following Placement of Implants Immediately after Extraction of teeth |
|
Scientific Title of Study
|
Clinical and Radiographic Evaluation of soft and hard tissue changes following placement of Implants at socket preserved sites and immediate implant placement with and without socket shield |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfSMuthukumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Dept.of Periodontics,
Faculty of Dental Sciences
Sri Ramachandra Institute of Higher Education and Research
Porur,Chennai-600116
Dept.of Periodontics,
Faculty of Dental Sciences
Sri Ramachandra Institute of Higher Education and Research
Porur,Chennai-600116
Thiruvallur
TAMIL NADU
600087
India |
| Phone |
9884118681 |
| Fax |
|
| Email |
muthukumars@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfSMuthukumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
RoomNo:5,Dept.of Periodontics,
Faculty of Dental Sciences
Sri Ramachandra Institute of Higher Education and Research
Porur,Chennai-600116
Room No:5,Dept.of Periodontics,
Faculty of Dental Sciences
Sri Ramachandra Institute of Higher Education and Research
Porur,Chennai-600116
Thiruvallur
TAMIL NADU
600087
India |
| Phone |
9884118681 |
| Fax |
|
| Email |
muthukumars@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ProfSMuthukumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room No:5,Dept.of Periodontics,
Faculty of Dental Sciences
Sri Ramachandra Institute of Higher Education and Research
Porur,Chennai-600116
Room No: 5, Dept.of Periodontics,
Faculty of Dental Sciences
Sri Ramachandra Institute of Higher Education and Research
Porur,Chennai-600116
Thiruvallur
TAMIL NADU
600087
India |
| Phone |
9884118681 |
| Fax |
|
| Email |
muthukumars@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research,Porur,Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
DrSMuthukumar |
| Address |
90,9th street,chowdry nagar,valasaravakkam,chennai-600087 |
| Type of Sponsor |
Other [self funded ] |
|
|
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 |
| Prof SMuthukumar |
Sri Ramachandra Dental College and Hospital |
Room No:5, Department of Periodontics,Faculty of Dental Sciences SriRamachandra Institute of Higher Education and Research, Porur,Chennai-600116
Thiruvallur
TAMIL NADU |
9884118681
muthukumars@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients requiring replacement of missing teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immeduiate Implant placement with or without socket shield |
1. Following administration of local anesthesia of the treatment site, either the tooth would be extracted and implant placed immediately are the tooth will be decoronated to the gingival level.
2. Thereafter, with the use of a long shank bur, the root will be carefully sectioned mesiodistally and longitudinally midway through the root with the canal as the reference, such that the labial and palatal halves are separated from each other entirely from the coronal to apical aspect.
3. Once the labial and palatal root halves are adequately separated a periotome will be inserted to carefully displace the palatal root section labially into the recess created by the sectioning bur and retrieve it with forceps.
4. The labial root section that remains in situ will then be instrumented on it’s inner aspect to inspect for immobility. 5.Thereafter, the coronal aspect of the root section will be reduced and shaped to within 1 mm above the alveolar socket crest as a crescent shaped concavity conforming to labial aspect of alveolus by a large round diamond bur.6.Following which implant will be placed palatally in to the socket using standard osteotomy procedure.
|
| Comparator Agent |
Socket Preservation with a combination Advanced Platelet Rich Fibrin (A-PRF) and De-Mineralised Bovine Bone Mineral (DBBM). |
• Following antibiotic administration, non-traumatic extraction of the tooth shall be performed with periotomes and forceps.
• The socket shall be thoroughly curetted, irrigated with sterile saline, and inspected for the presence of perforations, fenestration, or dehiscence.
• The socket shall be debrided and granulation tissue removed immediately following extraction.
• A-PRF clots will be cut into small pieces and mixed with DBBM particles to achieve a final volume of 1:1 of graft particulate to A-PRF.
For wound closure and soft tissue augmentation, a partially epithelized connective tissue graft will be harvested from the hard palate.
• After the graft being harvested, the complete donor area sutured using transverse mattress sutures . The graft will then be carefully inserted into the socket using a guiding suture and placed over the socket orifice and could be regarded as the lid of the socket.
• Follow-up evaluation at 4-weeks, 3-months and 4-months post-surgery will be done. Oral hygiene instructions will be reinforced throughout the study.
At 4-months post-surgery, the test sites will be re-entered for implant placement.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy adults who present with hopeless teeth indicated for extraction with type-1 extraction socket and are willing for implant placement.
2. Tooth indicated for extraction should be periodontally healthy.
3. Non smoker
|
|
| ExclusionCriteria |
| Details |
1. Systemically unhealthy
2. Teeth with present / past periodontal disease
3. Teeth with vertical root fractures on the buccal aspect
4. Teeth with horizontal fractures at / below bone level
5. Teeth with external / internal resorption of buccal part of root
6. Patients who are pregnant, intending to conceive or breast feeding
7. Received systematic corticosteroids, Immunosuppressive agents, radiation therapy, chemotherapy in past 2 months.
8. Subjects under Bisphosphonate therapy.
9. Subjects with allergies or sensitivity to alginate, latex.
10. Subjects participating in other clinical interventional studies.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the dimensional alterations in bone level (buccal plate) radiographically (CBCT) and clinically by transgingival probing as measured using indexed stents at baseline,3, 6 and 12 months. |
To assess the dimensional alterations in bone level (buccal plate) radiographically (CBCT) and clinically by transgingival probing as measured using indexed stents at baseline,3, 6 and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the soft tissue around the implant using the Pink Esthetic Score (PES), implant mobility and signs of peri – implantitis. Assessment of pain threshold and patient satisfaction using Visual Analogue Scale (VAS). |
baseline,3,6 and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
20/06/2019 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized controlled clinical trial comparing the dimensional alterations in hard and soft tissues following placement of implants immediately after extraction with and without socket shield and following placement of implants in socket preserved sites. A total of 75 patients will be recruited 25 in each group. The hard tissue changes will be evaluated using cbct at baseline 3,6 and 12 months. The soft tissue changes will be evaluated using the Pink Esthetic Scores at baseline 3,6 and 12 months. The purpose of the study is to find out the best possible technique for placement of implants immediately following extraction of teeth. The results of the study will be published after the completion of the trial. |