| 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
|
|
|
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
|
|
|
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.
|