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CTRI Number  CTRI/2024/10/076079 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two types of dental implants and how they affect the surrounding bone and gum tissue: a randomized clinical trial. 
Scientific Title of Study   A comparative in-vivo study between reverse conical neck and standard neck implants and its effect on crestal bone morphology and peri-implant soft tissue collar; a randomized clinical trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pinipe Christina 
Designation  Post Graduate 
Affiliation  GSL dental college 
Address  Department of periodontics, room no 10, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India, Pincode- 533296

East Godavari
ANDHRA PRADESH
533125
India 
Phone  7093271619  
Fax    
Email  christinaperio22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anupama Masapu 
Designation  Professor and head of the department 
Affiliation  GSL dental college 
Address  Department of periodontics, room no 10, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India, Pincode- 533296

East Godavari
ANDHRA PRADESH
533125
India 
Phone  9985313267  
Fax    
Email  anu3267@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pinipe Christina 
Designation  Post Graduate 
Affiliation  GSL dental college 
Address  Department of periodontics, room no 10, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India, Pincode- 533296

East Godavari
ANDHRA PRADESH
533125
India 
Phone  7093271619  
Fax    
Email  christinaperio22@gmail.com  
 
Source of Monetary or Material Support  
GSL dental college and Hospital 
 
Primary Sponsor  
Name  Pinipe Christina 
Address  Department of periodontics, room no 10, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India, Pincode- 533296 
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 
DrPinipe christina  GSL Dental college and hospital  Department of periodontics, room no 10, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India, Pincode- 533296
East Godavari
ANDHRA PRADESH 
7093271619

christinaperio22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GSL Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dental implants  Reverse conical/bevel neck implants 
Comparator Agent  Dental Implants   standard/parallel neck implants  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Posterior edentulous spaces with adequate ridge dimension for implant placement.
Presence of a minimum of 2 mm of keratinized mucosa at the buccal aspects in the implant zone.
Minimum crestal bone width of 5 mm and bone architecture without undercuts and presence of 1 mm of bone bucco-lingual to the planned position in a favorable prosthetic situation from pre- operative CBCT.
Vertical bone height from bone crest to top of mandibular canal of 12 mm or more; a mesio-distal width of 6–10 mm .
Minimum vertical distance of 5 mm from the crestal mucosa of the potential implant site to the opposing dentition.
Absence of periapical pathology adjacent to the edentulous site.
Patients who are motivated, highly compliant, with good oral hygiene practice. 
 
ExclusionCriteria 
Details  Anterior edentulous space.
Presence of active periodontal disease.
Patients with any systemic disease and medications that will interfere with treatment outcome.
Patients with known risk factors and risk modifiers which can influence the overall outcome of treatment were excluded from the study.
Pregnant and lactating women.
Persons who are not surgically fit for implant placement. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Radiographic crestal Bone levels around implant, Periimplant probing depth  baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between Mucosal thickness and primary outcomes  baseline 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) 24/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

The success of dental implants is influenced by the amount of bone surrounding the implant. The design of the implant collar, particularly the reverse conical neck design, can affect bone remodelling. This design is thought to reduce bone loss, redistribute stress, and improve soft tissue health and also provide the bone ring formation on crest module.  Matteo Danza, Chieti/Italy,(2009) conducted a study in which The concept of platform switching (PS)  can be successfully applied together with immediate loading as demonstrated in case series and histo-morphometrical evaluation in man. Starting from the platform switching  idea, this study elaborated the concept of Bone Platform Switching (BPS). The BPS is obtained by using dental fixture with a reverse conical neck. This type of implant gives an increased residual crestal bone volume around the implant neck and carries several advantages: a reduced mechanical stress in the crestal alveolar bone area, the repositioning of gingival papillae on the bone ring (that is the physiological condition), and a proper vascular supply to hard and bone tissue also in case of reduced inter-implant space. To verify if the concept of BPS really gives some advantages to reverse conical neck implants a retrospective analysis was performed on a case series of RCN implants. This study aims to compare the cresta bone loss and soft tissue health around standard neck implants and reverse conical neck implants to determine the effectiveness of the reverse conical design in preserving crestal bone and soft tissue.


 
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