CTRI Number |
CTRI/2021/04/032584 [Registered on: 06/04/2021] Trial Registered Prospectively |
Last Modified On: |
20/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Preventive Dentistry Other (Specify) [changes in thickness of gingiva will be observed] |
Study Design |
Other |
Public Title of Study
|
Evaluation of changes in gums, photographic parameters and patient reported outcomes after use of microneedling and i-PRF injection(Patients own blood) in patients with thin gums: A clinical study
|
Scientific Title of Study
|
Comparative evaluation of clinical, photographic parameters and patient reported outcomes in microneedling with and without i-PRF in thin gingival phenotype: A randomized clinical study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Priyanka Sonavane |
Designation |
MDS PART 1 |
Affiliation |
K M Shah Dental College and Hospital |
Address |
Room number 07, department of periodontology, K M Shah Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara, 391760
Vadodara GUJARAT 391760 India |
Phone |
9313746742 |
Fax |
|
Email |
psonavane04@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jasuma Rai |
Designation |
Professor and PG guide |
Affiliation |
K M Shah Dental College and Hospital |
Address |
Room number 07, department of periodontology, K M Shah Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara, 391760
Vadodara GUJARAT 391760 India |
Phone |
9974005760 |
Fax |
|
Email |
drjasumaj@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jasuma Rai |
Designation |
Professor and PG guide |
Affiliation |
K M Shah Dental College and Hospital |
Address |
Room number 07, department of periodontology, K M Shah Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara, 391760
Vadodara GUJARAT 391760 India |
Phone |
9974005760 |
Fax |
|
Email |
drjasumaj@gmail.com |
|
Source of Monetary or Material Support
|
KM shah dental college and hospital ,Sumanadeep Vidyapeeth At & Po. Pipariya, Ta Waghodia District Vadodara, Gujarat 391760 |
|
Primary Sponsor
|
Name |
Dr Priyanka Sonavane |
Address |
Room number 07, department of periodontology, K M Shah Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara, 391760 |
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 Priyanka Sonavane |
K M shah dental college and hospital |
Room number 07, department of periodontology, KM shah dental college and hospital sumandeep vidyapeeth waghodia, vadodara, 391760 Vadodara GUJARAT |
09313746742
psonavane04@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
healthy patients with thin gingival phenotype |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
1 Microneedling
2 i-PRF |
1 Microneedling is a procedure in which microinjuries created created on gingiva to improve the quality of gingiva.
2 Injectable platelet-rich fibrin (i-PRF) is one of the plasma-rich derivatives which is used for tissue regeneration in periodontal surgery. |
Comparator Agent |
Microneedling |
Microneedling is a procedure in which microinjuries created created on gingiva to improve the quality of gingiva using 30 guage microneedle .
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1 Systemically healthy adults
2 Non-smoker
3 Patients with thin biotype (probe visibility)in mandibular anterior teeth with gingival
4 Thickness < 0.8 mm
5 Healthy gingiva with GI score less than 1
6 No history of use of Antibiotic last 1 month
7 No history of previous periodontal surgery in last 6 months |
|
ExclusionCriteria |
Details |
1 Active orthodontic treatment
2 Fillings, missing or supernumerary mandibular
teeth
3 High frenal attachment ,TFO, bruxism
4 Pregnant and lactating women
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. GT measurement
2. Width of keratinized
tissue |
baseline , 10 days , 4 months , 7 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1 Plaque index
2 Gingival index
3 Patient reported outcomes measures (PROM)
4 Photographic analysis |
baseline , 10 days , 4 months , 7 months |
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/04/2021 |
Date of Study Completion (India) |
13/10/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
SUMMARY
Gingival phenotype is an important aspect of periodontium which
maintains the health of the tissue as well as plays a decisive role in
prediction of periodontal treatment outcomes. Thin gingival phenotype poses
certain risks of poor periodontal treatment outcome in cases of implant,
coronally advanced flap and other root coverage procedures and implants. In
this study a non-surgical treatment modalities are being employed in an attempt
to increase the thickness of thin gingival phenotype.
In this study the aim
was to
evaluation of clinical, photographic parameters and patient reported outcomes
in microneedling with and without i-PRF in thin gingival phenotype. Thirty Systemically
healthy subjects with thin gingival phenotype was included in this study. The
lower anterior teeth were randomly divided into two halves by flip coin method,
in which the one side is treated with Microneedling (MN) + i-PRF (Group 1) and
another was treated by Microneedling alone (Group 2). The procedure was
repeated for 4 times in an interval of 10 days. Measurement of Gingival
Thickness (GT), Width of Keratinized Tissue (WKT), Oral Hygiene Index (OHI),
Gingival Index (GI) and Patient reported outcome measurement (PROM) which
included Pain, swelling, discomfort and redness was assessed.
Follow up of all the patients
was done till 6 months. From
the baseline to 6 months, both the groups showed statistical significant
improvement in the gingival thickness (P < 0.001). No significant
improvement in WKG in both the groups. The intergroup comparison showed highly
statistical significant increment in GT. Photographic analysis by RGB and L* a*
b* showed highly statistical significant changes from baseline to 6 months. In
group 1 there was significant variation in PROM from baseline to 7 days. PROM
in group 2 showed statistical significant changes in Visual analogue scale and
redness. Overall better comfort was observed in group 2 in PROM.
Thus, this study concludes that microneedling along with i- PRF provides significant
improvement in thickness of gingiva. This study is first study of its kind to
conduct photographic analysis and patient reported outcomes to measure in
non-surgical periodontal therapy. The photographic analysis showed changes from
baseline to 6 months suggestive of changes in gingiva. Patient reported
outcomes measurement enable us to analyse the patient’s perception regarding
treatment which showed overall better comfort in microneedling group. Hence, this non-surgical
treatment modality can be used improve the gingival phenotype of the patients
with minimal discomfort and without need of surgery in cases of thin gingival
phenotype.
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