| 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
|
|
|
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
|
|
|
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
|
|
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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. |