| CTRI Number |
CTRI/2025/09/094807 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Gum Health in People With Dental Implants Compared to Tooth-Supported Bridges Over 6 Months |
|
Scientific Title of Study
|
Comparative of Soft Tissue Parameters Around Dental Implants and Tooth-Supported Fixed Partial Dentures :A 6-Month Split Mouth 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 |
Jaswitha V |
| Designation |
Assistant Professor |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH 522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8790994930 |
| Fax |
|
| Email |
drjaswithavperio@sids.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaswitha V |
| Designation |
Assistant Professor |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH 522509
India
ANDHRA PRADESH
522509
India |
| Phone |
8790994930 |
| Fax |
|
| Email |
drjaswithavperio@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Meghana Gangolu |
| Designation |
Assistant Professor |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH 522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8143458843 |
| Fax |
|
| Email |
drmeghanagperio@sids.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.V.Jaswitha |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences,Takkellapadu,522509 |
| 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 V Jaswitha |
Sibar Institute of dental Sciences |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
ANDHRA PRADESH 522509
India
Guntur
ANDHRA PRADESH |
8790994930
drjaswithavperio@sids.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, (2) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fixed partial denture |
• Patients aged 25–50 years requiring or having recently received either implant-supported single crowns or tooth-supported fixed partial dentures
• Systemically healthy individuals.
• Willingness to return for follow-up visits at 3 and 6 months post-placement.
|
| Intervention |
Implant |
Dental implants will be placed and restored following standardized surgical and prosthetic protocols. Patients will be followed up at 1st week, 2nd week, 3 months, and 6 months after prosthesis insertion for evaluation of soft tissue parameters including plaque index, gingival index, probing depth, bleeding on probing, mucosal/gingival recession, and width of keratinized mucosa
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 25–50 years requiring or having recently received either implant-supported single crowns or tooth-supported fixed partial dentures
Systemically healthy individuals.
Willingness to return for follow-up visits at 3 and 6 months post-placement.
|
|
| ExclusionCriteria |
| Details |
Any forms of tobacco users.
Pregnant and lactating women.
Subjects taking any medication which effect healing and bone metabolism.
Patients with systemic conditions affecting periodontal health
History of periodontal or peri-implant surgery within the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean probing pocket depth (mm) around implant-supported vs tooth-supported FPDs
Percentage of sites with bleeding on probing (BOP) around implant-supported vs tooth-supported FPDs
|
At baseline , 3 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Plaque Index (PI) score .
2)Gingival Index (GI) score.
3)Gingival/mucosal recession (mm
4)Width of keratinized mucosa (mm)
5)Radiographic marginal bone levels
|
Baseline , 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2025 |
| 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="0"
Months="9"
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
|
This clinical study aims to compare the health of gums and surrounding soft tissues around dental implants and tooth-supported fixed partial dentures bridges. A split-mouth design will be used where each patient receives an implant-supported prosthesis on one side and a tooth-supported prosthesis on the opposite side. A total of 15 patients 30 sites will be included. Clinical parameters such as plaque index, gingival index, probing pocket depth, bleeding on probing gingival/mucosal recession and width of keratinized mucosa will be evaluated. Patients will be followed at baseline 3 months and 6 months with the primary endpoint at 6 months. The study will help determine whether implants and tooth-supported bridges show differences in gum health over time. |