| CTRI Number |
CTRI/2024/05/067902 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Vestibuloplasty Techniques for Improved Denture Stability in Patients with Severe Mandibular Ridge Resorption: A Clinical Study |
|
Scientific Title of Study
|
Comparison of two vestibuloplasty techniques to evaluate denture stability in complete denture patients with severely resorbed anterior mandibular ridge: A Prospective Clinical 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 |
Prof Dr Nagaraj M |
| Designation |
Dean, Director Professor & HOD |
| Affiliation |
ESIC Dental College & Hospital |
| Address |
Department of Oral & Maxillofacial Surgery
ESIC Dental College & Hospital
Dr KN Katju Marg, Sector-15
Rohini
North East DELHI 110089 India |
| Phone |
9902677806 |
| Fax |
|
| Email |
deandc-roh.dl@esic.gov.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rohit Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
ESIC Dental College & Hospital |
| Address |
Room No- D1
Department Of Prosthodontics, ESIC Dental College & Hospital
Dr KN Katju Marg, Sector-15
Rohini Room No- D1
Department Of Prosthodontics, ESIC Dental College & Hospital
Dr. KN Katju Marg, Sector-15
Rohini North East DELHI 110089 India |
| Phone |
9742987218 |
| Fax |
|
| Email |
rks.prosthodontics@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rohit Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
ESIC Dental College & Hospital |
| Address |
Room No- D1
Department Of Prosthodontics, ESIC Dental College & Hospital
Dr KN Katju Marg, Sector-15
Rohini Room No- D1
Department Of Prosthodontics, ESIC Dental College & Hospital
Dr. KN Katju Marg, Sector-15
Rohini North East DELHI 110089 India |
| Phone |
9742987218 |
| Fax |
|
| Email |
rks.prosthodontics@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hall D1
Department of prosthodontics
Hall B1
department of oral surgery
ESIC Dental College & Hospital
Dr KN Katju Marg
Sector- 15A
Rohini - 110089
Delhi
India |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Kumar Singh |
| Address |
Hall D1
Department Of Prosthodontics
ESIC Dental College & Hospital Dr KN Katju Marg
Sector 15
Rohini- 110089
Delhi
India |
| Type of Sponsor |
Government medical college |
|
|
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 Rohit Kumar Singh |
ESIC Dental College & Hospital |
Hall D 1
Department Of Prosthodontics, ESIC Dental College & Hospital
Dr. KN Katju Marg, Sector-15
Rohini - 110089 North East DELHI |
9742987218
rks.prosthodontics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ESIC Dental College & Hospital, Sector-15, Rohini,New Delhi-110085 |
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 |
| Intervention |
Clark’s Vestibuloplasty |
A horizontal incision will be placed at the mucogingival junction in relation to the mandibular labial vestibule. The dissection in supraperiosteal fashion will be carried out up to the desired vestibular depth. The mucosa on the buccal side will be undermined and the mucosal flap will be sutured with resorbable synthetic vicryl 4-0 suture at the depth of the vestibule. The resultant raw area will be on the ridge surface. The raw area will be covered with a wet sterile collagen membrane and will be stabilized with an acrylic stent/splint.
Duration for intervention is 6 months |
| Comparator Agent |
Sulcus Deepening Vestibuloplasty |
The mandibular vestibular incision will be given and dissected up to the desired vestibular depth. The mucosal flap will be sutured with resorbable synthetic vicryl 4-0 suture. The resultant raw area will be in the vestibular depth. The raw area will be covered with a wet sterile collagen membrane and will be stabilized with an acrylic stent/splint. Duration for comparator agent is 6 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Edentulous patient with a minimum bone height of 15 mm and less than 5 mm of vestibular depth in the mandibular anterior region.
Patients with ASA (American Society of Anaesthesiology) class I and II conditions. |
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled systemic disorders like hepatic, respiratory, cardiac, endocrine, or metabolic impairment which make the patient unfit for surgical procedure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The pre-prosthetic surgery is expected to enhance the stability of the mandibular complete denture which will improve the quality of life of complete edentulous patients |
Patients will be checked on day zero, day 7, day 15, and in 4th week for satisfactory surgical wound healing. Only after satisfactory healing, we will proceed with the denture fabrication process. The denture will be delivered around 4-6 weeks after soft tissues show at least grade 4(very good) healing. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better retention for denture |
after 6 months of delivering the dentures |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="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
|
a Vestibuloplasty is a surgical procedure designed to deepen the
oral vestibule, which is the space between the lips, cheeks, and gums. This
procedure is commonly employed in pre-prosthetic surgery to address issues
related to the insufficient height of the alveolar ridge, and in periodontology
to augment the amount of keratinized gingiva. The alveolar ridge is the bony
ridge that contains the tooth sockets in the upper and lower jaws. An adequate
height of the alveolar crest is crucial for the stability and retention of
removable dentures, especially when implants are not used for support.1-2
Several conditions can contribute to the reduction of vestibular depth,
including a prolonged absence of teeth, traumatic injuries to the alveolar
ridge, or severe periodontitis (inflammation and infection of the supporting
structures of the teeth). When there is a lack of an adequate residual alveolar
ridge, it can compromise the successful rehabilitation with removable dentures.
Removable dentures are often preferred for economic reasons, making
vestibuloplasty an indispensable procedure in cases where the vestibular depth
is reduced.3-4 Many vestibular deepening techniques have been
described since the beginning of the era of surgery namely, Kazanjian, Godwin,
Trauner, Clark, Sulcus deepening, Obwegeser, Howe, Steinhauser, Tortorelli.
Vestibuloplasty repositions mucosa, and muscle insertions, and increases the denture
flange area in turn stability of the prosthesis. All procedures are associated
with varying degrees of success. Disadvantages associated with existing procedures
made the clinician rethink modifications so that the modifications can overcome
the disadvantages.
· This clinical study planned
to achieve adequate vestibular depth using Clark’s and sulcus deepening vestibuloplasty
so that stability of the mandibular denture will be improved. |