FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  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 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  
Status 
Not Applicable 
 
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. 

 


 
Close