| 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
|
|
|
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
|
|
|
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. |