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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  
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 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  
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 
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.

 
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