| CTRI Number |
CTRI/2024/04/065969 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the clinical severity and treating peri-implantitis surrounding dental implants in patients who recovered from COVID-19
|
|
Scientific Title of Study
|
A clinical evaluation of severity and management of peri-implantitis around dental implant in post COVID 19 patients- Randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Singh |
| Designation |
Professor Junior Grade |
| Affiliation |
King Georges Medical University |
| Address |
6th floor, Department of Prosthodontics Crown and Bridge, New Dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9794713840 |
| Fax |
|
| Email |
dr_mayank1983@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshya Kumar |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
6th floor, Department of Prosthodontics Crown and Bridge, New Dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9412119778 |
| Fax |
|
| Email |
lakshya79@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayank Singh |
| Designation |
Professor Junior Grade |
| Affiliation |
King Georges Medical University |
| Address |
6th floor, Department of Prosthodontics Crown and Bridge, New Dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9794713840 |
| Fax |
|
| Email |
dr_mayank1983@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics Crown and Bridge, Faculty of Dental Sciences, King Georges Medical University, Lucknow |
|
|
Primary Sponsor
|
| Name |
Council of Science and Technology U P |
| Address |
203/84, Nabiullah Road Bans Mandi, Qaisar Bagh
Lucknow
Uttar Pradesh
226018 |
| Type of Sponsor |
Research institution |
|
|
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 Mayank Singh |
King Georges Medical University |
PG Clinic, 6th floor, Department of Prosthodontics Crown and Bridges, New Dental Building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH |
9794713840
dr_mayank1983@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T857||Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mechanical debridement with adjunct antimicrobial therapy |
Following mechanical debridement with the help of a sterile ultrasonic scaler and titanium curettes. Patients will be given antimicrobial tetracycline gel in the peri-implant pocket depth. Post intervention follow up done upto 2 years |
| Intervention |
Mechanical debridement with adjunct laser therapy |
Following mechanical debridement with the help of a sterile ultrasonic scaler and titanium curettes. After proper irrigation with the saline laser will be placed inside the gingival sulcus till the bottom slowly and left in situ for 2 minutes. After 3 minutes of placement, the peri-implant sites will be exposed to the laser for 10 s at each site.
Following this follow will be done upto 2 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Post covid-19 healthy subjects will be recruited who have SPO2, Pulse rate, Blood pressure within standard limits.
Ability to understand the procedure and provide informed consent assessed by decision making capacity and approaches before being included in the study.
Diagnosis of peri-implantitis based on the soft tissue around the implant showing obvious inflammatory symptoms, bone loss revealed by X-ray examination and probable haemorrhage and suppuration.
At least 2 implant site with periodontal PD ≥4- 6 mm.
Plaque Index around the implant ≥ 2 points
Visible bleeding around the implant after probing.
CAL ≤ 3 mm. |
|
| ExclusionCriteria |
| Details |
Current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or chewing tobacco.
History of drug abuse or alcoholism within the past 5 years
Severe bruxism or clenching habit.
Significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
History of systemic disease that precludes standard dental implant therapy.
Past history of implant repair and failure over past 6 months. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical evaluation of Peri-implant plaque index (PI), BOP, PPD, CAL.
2. Radiographically evaluation of Marginal bone loss.
3. Evaluation of OPG levels in Peri-implant sulcular fluid (PISF). |
Upto 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluation of implant stability by Resonance frequency test.
2. Evaluation of pink and white aesthetic score. |
Upto 2 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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)
|
AIM AND OBJECTIVE:
The objectives of the study are to compare and evaluate the following parameters at predetermined time intervals.
ï‚· To evaluate and compare the effect of two different treatment modalities on peri-implant soft tissues, marginal bone loss, healing, implant stability and overall survival rate. ï‚· To evaluate aesthetic outcomes and oral hygiene maintenance. ï‚· To evaluate bone biomarker (OPG) between the two groups. ï‚· Patient compliance and experience.
PLACE OF STUDY:
Department of Prosthodontics and Crown & Bridge, Faculty of Dental Sciences, King George’s Medical University, Lucknow, India.
MATERIALS AND METHODS:
A randomized controlled clinical trial of 6 month follows up period is designed in which approx. Sixty individuals (30 in the test-group and 30 in the control-group) will be derived from prosthodontics department of King George’s Medical University, Lucknow (U.P). Patient will be considered eligible according to predefined inclusion and exclusion criteria. This study will be carried out for 2 years along with the follow up of the patients. Informed consent will be taken from each patient who will be participating in the study. Ethical clearance will be obtained from the ethical committee. Randomisation will be done using computer generated sequence of random numbers and allocation will be done using sealed envelopes. The treatment in two groups will be given as under-
(a) Test group: patients underwent mechanical debridement with adjunct laser therapy; and (b) Control group: patients underwent mechanical debridement with adjunct antimicrobial therapy.
ASSESMENT OF CRITERIA FOR EVALUATION: - I) Clinical Parameter: i. Periimplant plaque index (PI) ii. Bleeding on probing (BOP) iii. Probing pocket depth (PPD) by using plastic probe at six sites of implant (mesio, disto, midbuccal, mesio, disto, mid lingual/palatal). iv. Clinical attachment loss (CAL) II) Implant stability / mobility: By resonance frequency test/ percussion test. III) Radiographic parameter: Peri-implant marginal bone levels/crestal bone loss (CBL) at follow ups. IV) Aesthetic outcomes: Pink esthetic score White esthetic score V) Healing and Pain at each follow up. VI) Human Osteoprotegerin (OPG) ELISA test from Peri-implant sulcular fluid (PISF).
Statistical analysis-For the significant value of research data SPSS softwarewill be used. |