| CTRI Number |
CTRI/2018/06/014610 [Registered on: 25/06/2018] Trial Registered Prospectively |
| Last Modified On: |
20/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess the effect of change in bone levels following implant placement immediately after removal of tooth with and without socket shield (leaving a tooth root section) |
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Scientific Title of Study
|
Clinical and radiographic evaluation of dimensional alterations of soft and hard tissues following immediate implant placement with and without socket shield - A randomized controlled clinical trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Das |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Department of Periodontology Faculty of Dental Sciences Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600116, Tamilnadu, India
Department of Periodontology Faculty of Dental Sciences Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600116, Tamilnadu, India
Chennai
TAMIL NADU
600 116
India |
| Phone |
9790754096 |
| Fax |
091-44-45928643 |
| Email |
dasdivya1893@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Muthukumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Department of Periodontology Faculty of Dental Sciences Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600116, Tamilnadu, India
Department of Periodontology Faculty of Dental Sciences Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600116, Tamilnadu, India
Chennai
TAMIL NADU
600116
India |
| Phone |
9884118681 |
| Fax |
091-44-45928643 |
| Email |
praveen_dr@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Muthukumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Department of Periodontology Faculty of Dental Sciences Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600116, Tamilnadu, India
Department of Periodontology Faculty of Dental Sciences Sri Ramachandra Medical College and Research Institute, Porur, Chennai 600116, Tamilnadu, India
Chennai
TAMIL NADU
600116
India |
| Phone |
9884118681 |
| Fax |
091-44-45928643 |
| Email |
praveen_dr@hotmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Divya Das |
| Address |
Divya Das,Post graduate, Department of Periodontology,Faculty of Dental Sciences, Sri Ramachandra Medical College and Research Institute, Porur , Chennai 600 116, Tamilnadu |
| Type of Sponsor |
Other [Self funded] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Divya Das |
Sri Ramachandra Medical College and Research Institute |
Department of Periodontology, Room No 5, Faculty of Dental Sciences, Sri Ramachandra Medical College and Research Institute,Porur
Chennai
TAMIL NADU |
9790754096
dasdivya1893@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Sri Ramachandra Medical College and Research Institute |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Implant placement without socket shield |
Following administration of local anesthesia of the treatment site, atraumatic extraction of the tooth will be performed using periotome and forceps.Periotome will be driven 3 – 5 mm apically to sever the dentogingival and dentoalveolar fibres.Extraction forceps will be used to luxate the tooth mesiodistally using slow, rotating pull force and buccolingual movement will be avoided to prevent the fracture of the buccal plate.After tooth extraction, dimensions of socket will be recorded through direct measures and at baseline the buccal-lingual and vertical dimensions of extraction socket will be recorded using indexed stents and UNC 15 periodontal probes (Hu-Friedy Mfg. Co., Chicago, IL, USA) and a curette will be used to conï¬rm that the location of the buccal plate is intact.Following which implant will be placed in the socket using standard osteotomy procedure. |
| Intervention |
Socket shield preparation with implant placement |
Following administration of local anesthesia of the treatment site, the tooth will be decoronated to the gingival level.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.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.The labial root section that remains in situ will then be instrumented on it’s inner aspect to inspect for immobility.Thereafter, the coronal aspect of the root section will be reduced and shaped to within 1 mm above the alveolar socket crest as a cresent shaped concavity conforming to labial aspect of alveolus by a large round diamond bur.Again the socket is thoroughly rinsed with saline and the root section inspected with a probe for immobility.The dimensions of socket will be recorded through direct measures and at baseline the buccal-lingual and vertical dimensions of extraction socket will be recorded using indexed stents using UNC 15 periodontal probes (Hu-Friedy Mfg. Co., Chicago, IL, USA).Following which implant will be placed palatally in to the socket using standard osteotomy procedure. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy adults who present with hopeless teeth indicated for extraction and are willing for immediate implant placement.
Tooth indicated for extraction should be periodontally healthy.
Non smoker
|
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| ExclusionCriteria |
| Details |
Systemically unhealthy
Teeth with present / past periodontal disease
Teeth with vertical root fractures on the buccal aspect
Teeth with horizontal fractures at / below bone level
Teeth with external / internal resorption of buccal part of root
Patients who are pregnant, intending to conceive or breast feeding
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the dimensional alterations in bone level (buccal plate) radiographically (CBCT) and clinically by transgingival probing at baseline, 3 months and at 6 months. |
Baseline, 3 months and at 6 months |
|
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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). |
The soft tissue around the implant will be assessed using the Pink Esthetic Score (PES). Assessment of implant mobility and signs of peri – implantitis will be evaluated. Assessment of pain threshold and patient satisfaction using Visual Analogue Scale (VAS)at baseline, 3 months and at 6 months. |
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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" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/06/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This randomized double blinded, parallel group active controlled clinical trial aims to compare clinically and
radiographically (CBCT) the dimensional alterations in soft and hard tissues following
immediate implant placement with and without socket shield at baseline, 3 and 6 months.
|