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CTRI Number  CTRI/2025/11/097333 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Evaluating Short-Term Survival and Comfort of Smooth Surface Implants in Patients Treated for Periodontal Disease.” 
Scientific Title of Study   Short Term Survival Rate and Patient Satisfaction in Periodontally Compromised Patients Rehabilitated with Smooth Surface Bi-cortical implants. 
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 Megnel Leona Menezes 
Designation  Post graduate Student 
Affiliation  Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics Room 4 1st Floor Faculty of Dental Sciences Ramaiah University of Applied Sciences Bangalore 560054 India

Bangalore
KARNATAKA
560054
India 
Phone  9740548060  
Fax    
Email  megnelmenezes@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravishankar K 
Designation  Professor 
Affiliation  Faculty of Dental Sciences , Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics Room 4 1st Floor Faculty of Dental Sciences Ramaiah University of Applied Sciences Bangalore 560054 India

Bangalore
KARNATAKA
560054
India 
Phone  9886056303  
Fax    
Email  ravishankar.pr.ds@msruas.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ravishankar K 
Designation  Professor 
Affiliation  Faculty of Dental Sciences , Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics Room 4 1st Floor Faculty of Dental Sciences Ramaiah University of Applied Sciences Bangalore 560054 India

Bangalore
KARNATAKA
560054
India 
Phone  9886056303  
Fax    
Email  ravishankar.pr.ds@msruas.ac.in  
 
Source of Monetary or Material Support  
Department of Prosthodontics, Room no 4, 1st Floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences , M S R Nagar, Mathikere, Bengaluru, Karnataka 560054 India 
 
Primary Sponsor  
Name  Dr Megnel Leona Menezes 
Address  Department of Prosthodontics Room 4 1st Floor Faculty of Dental Sciences Ramaiah University of Applied Sciences Bangalore 560054 India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Megnel Leona Menezes  Ramaiah Dental Hospital   Department of Prosthodontics Room 4 1st Floor Faculty of Dental Sciences Ramaiah University of Applied Sciences Bangalore 560054 India
Bangalore
KARNATAKA 
9740548060

megnelmenezes@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UNIVERSITY ETHICS COMMITTEE FOR HUMAN TRIALS APPROVAL CERTIFICATE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Partially edentulous arch 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Basal Implants in Periodontally compromised patients  Periodontally compromised patients with partial edentulism will be rehabilitated with Basal implants and evaluated for parameters immediately and after 6 months. 
Comparator Agent  Basal implants in periodontally healthy patients  Periodontally healthy patients with partial edentulism will be rehabilitated with Basal implants and evaluated for parameters immediately and after 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Systemically healthy patients
2) Partially edentulous maxillary and mandibular ridges

 
 
ExclusionCriteria 
Details  1) Uncontrolled diabetes mellites
2) Age less than 18 years
3) History of heavy smoking.
4) Patients having metabolic and bone diseases
5) Patients undergoing radiotherapy or chemotherapy
6) Recent history of cardiac arrest, stroke, haematological disorders.
7) Pregnant or lactating women
8) Patients who refuse to provide with informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess clinical parameters (presence of exudate; pain levels; primary implant stability) and radiographic parameters (bone loss and radiolucency) around the implant for periodontally healthy and compromised individuals at baseline and 6 months after implant placement.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare patient satisfaction scores of both periodontally healthy and compromised individuals at baseline and at six months after the implant restoration  6 months 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 2/ Phase 3 
Date of First Enrollment (India)   23/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Rehabilitation of missing teeth with a definitive solution has become an aspiration not only to the patients but also professionals and introduction of dental implants has led to a new array of expectations and scope for immense research and development of various implant concepts.  Implant prosthesis not only replaces the missing teeth offering aesthetics but also restores function. Although implants may seem like the best treatment approach, proper case study and patient selection is crucial in determining the long-term implant success. (Herrmann et al 2005)

A retrospective study conducted among 128 single tooth conventional implant placed resulted in a survival rate of 91.60% where the main reasons for failure were inadequate or improper oral hygiene, periodontal health and occlusal stress. (Shailesh Jain et al 2024). 

A recent study evaluated the marginal bone loss and bleeding on probing between machined (smooth surface) and rough surface implants suggesting that these parameters were in slight favour of machined implants (Hussein et al., 2024). Based on the conclusion in a systematic review on rough surface implants published in the year 2016, patients without history of periodontitis exhibited better implant outcome in terms of survival and success when compared to patients treated with periodontitis. (Constantine T. T. Ong, 2008). On the other hand, short dental implants placed in patients treated with generalized aggressive periodontitis did remain functionally stable. However, these implants showed higher levels of clinical attachment loss (Akram et al., 2019). Keeping this in mind placement of implants in periodontally diseased individuals poses an uncertainty in implant survival and success.

The conventional implants come with an added disadvantage with a few months of healing period leading to prolonged edentulism in patients (Ghalaut et al., 2019). Therefore, a better treatment approach for rehabilitating periodontally compromised patients with implants is much needed.

An emerging concept of bi-cortical or basal implants has gained popularity with its ease of placement and shorter surgical time when compared to conventional implants. This system is designed specifically to obtain anchorage from basal cortical bone. This cortical bone being more dense and less prone to infection provides excellent support and stability to implants. (Sikri A., et al., 2023). A prospective study where 157 basal implants placed in atrophied ridges concluded a cumulative survival of 97.5% with no signs of tenderness or periimplantitis during the observation period of 1 year (Patel et al., 2021). A 5 month evaluation done in an animal study demonstrated that bone loss progressed faster at rougher sand blasted acid etched titanium surface suggesting higher chances of peri-implantitis when compared to polished surfaces (Berglundh et al., 2007).


Aim of the study:  The aim of the study is to evaluate the short-term survival rate and patient satisfaction in periodontally compromised patients rehabilitated with smooth surface bi-cortical implants.

 

 

Objectives of the study:

1)      To assess clinical parameters (presence of exudate; pain levels; primary implant stability) and radiographic parameters (bone loss and radiolucency) around the implant for periodontally healthy and compromised individuals at baseline and 6 months after implant placement.

2)      To evaluate and compare patient satisfaction scores of both periodontally healthy and compromised individuals at baseline and at six months after the implant restoration

3)      To compare the recorded clinical and radiographic parameters of both periodontally healthy and compromised individuals at baseline and six months after the implant restoration.


 
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