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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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