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

Completed

Conditions: healthy patients with thin gingival phenotype

Registration Number: CTRI/2021/04/032584

Lead Sponsor: Dr Priyanka Sonavane

Brief Summary: SUMMARYGingival phenotype isan important aspect of periodontium whichmaintains the health of the tissue as well as plays a decisive role inprediction of periodontal treatment outcomes. Thin gingival phenotype posescertain risks of poor periodontal treatment outcome in cases of implant,coronally advanced flap and other root coverage procedures and implants. Inthis study a non-surgical treatment modalities are being employed in an attemptto increase the thickness of thin gingival phenotype.

In this study the aimwas toevaluation of clinical, photographic parameters and patient reported outcomesin microneedling with and without i-PRF in thin gingival phenotype.Thirty Systemicallyhealthy subjects with thin gingival phenotype was included in this study. Thelower 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) andanother was treated by Microneedling alone (Group 2). The procedure wasrepeated for 4 times in an interval of 10 days. Measurement of GingivalThickness (GT), Width of Keratinized Tissue (WKT), Oral Hygiene Index (OHI),Gingival Index (GI) and Patient reported outcome measurement (PROM) whichincluded Pain, swelling, discomfort and redness was assessed.

Follow up of all the patientswas done till 6 months. Fromthe baseline to 6 months, both the groups showed statistical significantimprovement in the gingival thickness (P < 0.001). No significantimprovement in WKG in both the groups. The intergroup comparison showed highlystatistical significant increment in GT. Photographic analysis by RGB and L\* a\*b\* showed highly statistical significant changes from baseline to 6 months. Ingroup 1 there was significant variation in PROM from baseline to 7 days. PROMin group 2 showed statistical significant changes in Visual analogue scale andredness. Overall better comfort was observed in group 2 in PROM.

Thus, this study concludes that microneedling along with i- PRF provides significantimprovement in thickness of gingiva. This study is first study of its kind toconduct photographic analysis and patient reported outcomes to measure innon-surgical periodontal therapy. The photographic analysis showed changes frombaseline to 6 months suggestive of changes in gingiva. Patient reportedoutcomes measurement enable us to analyse the patientâ€™s perception regardingtreatment which showed overall better comfort in microneedling group. Hence, this non-surgicaltreatment modality can be used improve the gingival phenotype of the patientswith minimal discomfort and without need of surgery in cases of thin gingivalphenotype.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 25

Inclusion Criteria

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.

Exclusion Criteria

1 Active orthodontic treatment 2 Fillings, missing or supernumerary mandibular teeth 3 High frenal attachment ,TFO, bruxism 4 Pregnant and lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.GT measurement	baseline , 10 days , 4 months , 7 months
2.Width of keratinized	baseline , 10 days , 4 months , 7 months
tissue	baseline , 10 days , 4 months , 7 months

Secondary Outcome Measures

Name	Time	Method
1 Plaque index	2 Gingival index

Trial Locations

Locations (1): K M shah dental college and hospital
🇮🇳
Vadodara, GUJARAT, India
K M shah dental college and hospital
🇮🇳Vadodara, GUJARAT, India
Dr Priyanka Sonavane
Principal investigator
09313746742
psonavane04@gmail.com