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CTRI Number  CTRI/2025/07/090767 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of effectiveness of wing shaped implant component and a membrane in vertical and horizontal ridge defect restoration around dental implants 
Scientific Title of Study   Comparison of clinical effect of winged abutment and guided bone regeneration membrane for vertical and horizontal ridge augmentation around dental implants a randomized controlled trial 
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 E SANGEETHA 
Designation  I yr MDS Periodontology 
Affiliation  Karpaga vinayaga institute of dental sciences 
Address  Room No. 7 Third floor Department of Periodontology Karpaga Vinayaga Institute of Dental Sciences GST Road, Chinnakolambakkam Maduranthagam(tk), Kanchipuram Dist, TN-603308

Vellore
TAMIL NADU
632508
India 
Phone  9344148021  
Fax    
Email  drsangeetha2397@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ANIZ A 
Designation  Professor and Head Of The Department 
Affiliation  Karpaga Vinayaga Institute Of Dental Sciences 
Address  Room No. 7 Third floor Department of Periodontology Karpaga Vinayaga Institute of Dental Sciences GST Road, Chinnakolambakkam Maduranthagam(tk), Kanchipuram Dist, TN-603308

Chennai
TAMIL NADU
600102
India 
Phone  9884233240  
Fax    
Email  anizmds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr E SANGEETHA 
Designation  I yr MDS 
Affiliation  Karpaga vinayaga institute of dental sciences 
Address  Room No. 7 Third floor Department of Periodontology Karpaga Vinayaga Institute of Dental Sciences GST Road, Chinnakolambakkam Maduranthagam(tk), Kanchipuram Dist, TN-603308

Vellore
TAMIL NADU
632508
India 
Phone  9344148021  
Fax    
Email  drsangeetha2397@gmail.com  
 
Source of Monetary or Material Support  
Karpaga Vinayaga Institute Of Dental Science, GST Road, Chinnakolambakkam, Palayanoor, Chengalpattu district- 603308 
 
Primary Sponsor  
Name  E Sangeetha 
Address  No,1/80 Selliamman kovil street, Sumaithangi, Walaja taluk, Ranipet District-632508 
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 
E Sangeetha  Dr E SangeethaKarpaga Vinayaga Institute Of Dental Science  Room no 7 Department of periodontology Third floor GST ROAD,CHINNA KOLAMBAKKAM, PALAYANOOR(PO), CHENGALPATTU(DT)603308. MADHURANTHAGAM(TK)
Kancheepuram
TAMIL NADU 
9344148021

drsangeetha2397@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, KIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ridge augmentation for vertical and horizontal bone defects.  In case of a ridge defect, it is challenging to place an implant; to overcome this, ridge augmentation is the treatment of choice for better implant stability by different membranes. Duration- 2 years 
Comparator Agent  Winged and Guided bone regeneration membrane  Ridge augmentation around dental implants using winged abutment and Guided bone regeneration membrane 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Siebert’s Class III – Both vertical and horizontal bone loss.
2. An indication for a fixed implant-retained prosthesis.
3. Insufficient bone height for insertion of dental implants.
4. Absence of previously treated periodontal disease.
5. Ability to understand and accept the requirements of the study.
 
 
ExclusionCriteria 
Details  1.Medical conditions that compromised tissue healing (osteoporosis, haemophilia, anaemia, etc.)
2.Treatment with an interfering medication (bisphosphonate or steroid therapy).
3.Radiation therapy within the last 2 years.
4.Pregnancy or lactating women.
• H/O smoking habit
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To restore both horizontal and vertical bone around dental implants using a winged abutment abutment, with a follow-up of 6 months.  follow up in 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate bone gain after reconstructive procedure using radiographic imaging (CBCT) and stability of implant using resonance frequency analysis follow up of 3 months and 6 months.  • To evaluate bone gain after reconstructive procedure using radiographic imaging (CBCT) and stability of implant using resonance frequency analysis follow up of 3 months and 6 months. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   10/11/2025 
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 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  

The alveolar ridge, a component of the periodontium, is crucial for maintaining both natural teeth and dental implants. Sufficient bone volume at the implant site is essential for achieving favorable biomechanics and long-term aesthetic results. After tooth loss, the alveolar bone experiences dimensional changes due to factors like periodontal disease, trauma, and pathology. These changes typically occur immediately following extraction and result in loss of ridge dimensionsin both horizontal and vertical directions, highlighting the importance of ridge augmentation for successful implant therapy.

Ridge augmentation around dental implants is essential for creating adequate bone volume and ensuring successful implant placement, especially in cases with significant bone loss or insufficient bone width and height.

A successful ridge augmentation depends majorly on tooth critical factors one is the type of graft used and the other is the stabilization of graft material.Although different types of membranes and titanium meshes are available to stabilize the graft additional screws or tags are needed to stabilize the membrane itself which stabilizing screw itself cause a wound and loss of bone around the implants.

To overcome this, tent pole abutments have been introduced to stabilize the graft in the vertical direction, but they lack horizontal stabilization.To overcome the above limitations, a modification of the abutment with wings will be introduced to support both horizontal and vertical components.

The winged abutments are tailor-made according to the type of defect and edentulous space.The winged abutments are made from castable abutments using cobalt chromium.

Although Various grafts and methods can be employed to achieve ridge augmentation, each with its specific techniques, advantages,and considerations ridge augmentationremains challenging. The study evaluates the efficacy of winged abutment and guided bone regeneration membranes in vertical and horizontal ridge augmentation around implants.

 
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