| CTRI Number |
CTRI/2024/10/075094 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of two types of implant placement
techniques on gum health at various time interval. |
|
Scientific Title of Study
|
Comparison of soft tissue volumetric change between conventional protocol and tentpole technique in implant rehabilitation-A split mouth, pilot 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 |
Aswathy S Nair |
| Designation |
Junior Resident |
| Affiliation |
AIIMS DELHI |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, Sri
aurobindo garg, Ansari Nagar East, Ansari Nagar, New Delhi
New Delhi DELHI 110029 India |
| Phone |
8660923955 |
| Fax |
|
| Email |
aswathysnairtvr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aditi Nanda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS DELHI |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, Sri
aurobindo garg, Ansari Nagar East, Ansari Nagar, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aditi Nanda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS DELHI |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, Sri
aurobindo garg, Ansari Nagar East, Ansari Nagar, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Aswathy S Nair,Junior Resident, Department of Prosthodontics, Centre for Dental Education and
Research, AIIMS |
|
|
Primary Sponsor
|
| Name |
Aswathy S Nair |
| Address |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, Sri
Aurobindo Garg, Ansari Nagar East, Ansari Nagar, New
Delhi-110029 |
| 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 Aswathy S Nair |
Centre for Dental Education and Research |
2 nd Floor, Department of Prosthodontics, Centre for Dental
Education and Research, All India Institute of Medical Sciences, Sri
Aurobindo Garg, Ansari Nagar East, Ansari Nagar, New
Delhi-110029 New Delhi DELHI |
8660923955
aswathysnairtvr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Implants placed using conventional protocol |
1. To compare volumetric change in soft tissue thickness between implants placed with conventional protocol and implants placed with tent pole technique over a duration of 9 months. |
| Intervention |
Implants placed using soft tissue tentpole technique |
To compare volumetric change in soft tissue thickness between implants placed with conventional protocol and implants placed with tent pole technique over a duration of 9 months. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring placement of implants for replacement of bilateral missing tooth site bound by natural teeth.
2.Adequate bone height and width after extraction to accommodate the implant without impinging on vital structures in either maxillary or mandibular arches.
3.Well healed partially edentulous site
4.No bone augmentation procedures before and after implant placement
5.Full mouth plaque and bleeding scores less than 15%
6.Good oral hygiene and periodontal status of remaining dentition.
7.Available for follow up.
8.With positive informed consent.
9.Both the edentulous areas having antagonist teeth.
|
|
| ExclusionCriteria |
| Details |
1.Bone metabolic disorders such as osteoporosis, osteomalacia, rickets affecting surrounding bone health.
2.Vertical soft tissue thickness of less than 2mm in the implant site
3.History of radiotherapy in head and neck region.
4.Current habit of smoking or alcohol or drug abuse.
5.Systemic conditions as uncontrolled diabetic and hypertensive patients and cardiovascular conditions affecting the integrity of implant or connective tissue health surrounding the implant.
6.Bleeding dyscrasias or under anticoagulant therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| vertical soft tissue thickness |
Baseline,4 months, 9months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare volumetric changes in soft tissue thickness in implants placed by conventional technique and with tentpole technique |
Before implant placement(baseline)(T1),after second stage(T2),and at 9 months
|
|
|
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 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A
method to increase soft tissue thickness without the use of any intervening
graft materials by positioning and suturing soft peri-implant tissues over a healing
abutment, sometimes referred to as tenting technique. This technique involves expanding the soft tissue volume
and prevents contraction of soft tissue matrix as opposed to conventional
submerged protocol of placing a primary healing abutment flush with the implant
followed by flap approximation. A stable increase in vertical bone height is
achieved by this tentpole procedure when used along with bone graft as it
prevents displacement of graft and its physiologic resorption. This method plays an important role in
bone growth and reduces graft material resorption. Tent pole technique is a
more conservative technique which reduces the surgical time and dexterity when compared
to use of grafts. This technique can be considered as a kinder way of soft
tissue augmentation. Although the use of tentpole
technique has been documented in literature , how effective this
technique is in comparison to conventional technique is yet to be investigated. Therefore, this study is designed to compare the soft tissue changes
observed around an implant rehabilitated using soft tissue tentpole protocol
and conventional technique. |