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CTRI Number  CTRI/2024/06/069675 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 23/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Decreasing gum enlargement and deposits on teeth using small needles to make puncture holes on the gums and placing coconut oil and Vitamic C 
Scientific Title of Study   The effectiveness of micro needling technique using coconut oil and vitamin C on the severity of gingival inflammation and plaque accumulation in patients with Stage I Periodontitis – A Randomized clinical 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  Joshua Carlos Misquita 
Designation  Post graduate student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu Kodagu KARNATAKA 571218 India

Kodagu
KARNATAKA
571218
India 
Phone  9545476404  
Fax    
Email  dr.joshuacm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Joshua Carlos Misquita 
Designation  Post graduate student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu Kodagu KARNATAKA 571218 India

Kodagu
KARNATAKA
571218
India 
Phone  9545476404  
Fax    
Email  dr.joshuacm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Walvekar 
Designation  Professor and Head of Department 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu Kodagu KARNATAKA 571218 India

Kodagu
KARNATAKA
571218
India 
Phone  9480085687  
Fax    
Email  amitakw@rediffmail.com  
 
Source of Monetary or Material Support  
Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu KARNATAKA 571218 India 
 
Primary Sponsor  
Name  Joshua Carlos Misquita 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu  
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 Joshua Carlos Misquita  Coorg Institute of Dental Sciences  Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu Kodagu KARNATAKA
Kodagu
KARNATAKA 
9545476404

dr.joshuacm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board , Coorg Institute Of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Micro needling and coconut oil   After oral prophylaxis, bleeding points will be made from maxillary canine to canine with micro needle dermal pen followed by application of coconut oil on the site at first visit 
Intervention  Micro needling and Vitamin C  After oral prophylaxis, bleeding points will be made from maxillary canine to canine with micro needle dermal pen followed by application of Vitamin C on the site at first visit 
Comparator Agent  Scaling and root planing  Scaling and root planing will be done at first visit. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1)Male and female health-conscious subjects.
2)Age ranges from 18-40 years.
3)Subjects suffering from moderate to severe gingival inflammation.
4)Redness, bleeding and inflammation of the aesthetic area (upper six anterior teeth).
5)Presence of plaque & calculus on dental surfaces.
6)Undergone no previous treatment that had affected gingival health.
7)Willingness and ability to complete the clinical trial.
 
 
ExclusionCriteria 
Details  1)Poorly motivated and/or poorly collaborating subject.
2)Subject undergoing treatment with hormones.
3)Subject allergic to coconut.
4)Subject with bone loss or osteoporosis.
5)Missing one or more of the upper anterior teeth.
6)Medication induced gingival enlargement.
7)Subject with smoking and other tobacco-related habits.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Micro needling with Vitamin C and Coconut oil decreases gingival inflammation and plaque accumulation in patients with stage I periodontitis  Decrease in plaque accumulation and gingival inflammation after 1 week, 2 weeks and 4 weeks after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Scaling and root planing with micro needling decreases gingival inflammation and plaque accumulation in patients with stage I periodontitis as compared with Vitamin C and coconut oil  1 week, 2 weeks , 4 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/11/2024 
Date of Study Completion (India) 14/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

·       Subjects with severity of gingival inflammation and plaque accumulation will be selected from the Department of Periodontics OPD, Coorg Institute of Dental Sciences, Karnataka

·       Before the start of the study, written consent will be taken from the subjects of all the groups.

·       All subjects were subjected to professional mechanical scaling via a Piezoelectric ultrasonic scaler to remove calculus and soft deposits.

·       In addition, they were given oral hygiene instructions before treatment, including proper tooth brushing techniques and flossing only.

·       No mouthwash (MW) prescribed to the subjects.

·       Subjects were allocated randomly to either of the following groups;

·       18-40 years old subjects with severity of gingival inflammation and plaque accumulation who were treated with topical coconut oil using derma pen will be allocated in Group A and 18–40-year-old subjects with severity of gingival inflammation and plaque accumulation who were treated with vitamin C paste solution using derma pen will be allocated in Group B using random sampling method.

·       For each subject in Group A local anaesthesia of 2% lignocaine (1:80,000 adrenaline) was administered by infiltration technique in the anterior maxillary region.

·       To microneedle the mucosa, derma pen needles (head/subject) were used in an intermittent stamp like motion on the sextant gingival area for 30-40s/tooth with a depth of 1.5mm.

·       When uniform bleeding pinpoints were observed, coconut oil were applied by cotton roll on the upper anterior region of the gingiva (gingival sulcus, gingival margin and attached gingiva from canine to canine in a circular motion.

·       The cotton roll was left on the keratinized gingiva for 5 mins.

·       Subject were instructed to refrain from drinking acidic or hot beverages for 24hr and to not brush their teeth for 1 day to avoid any mechanical trauma to the gingiva.

·       Each subject will be reviewed for evaluation at four time points.

·       The first tissue evaluation of Micro needling technique will be scheduled before treatment (baseline).

·       Clinical examination will be done 1 week after treatment, 2 weeks after treatment & 4 weeks after treatment.

·       For each subject in Group B local anaesthesia 2% lignocaine (1:80000 adrenaline) was administered by infiltration technique in the anterior maxillary region.

·       To microneedle the mucosa, derma pen needles (head/subject) were used in an intermittent stamp like motion on the sextant gingival area for 30-40s/tooth with a depth of 1.5mm.

·       When uniform bleeding pinpoints were observed on all areas of gingiva, the gingival mucosa was irrigated with a saline solution and sterile gauze was applied to dry the area.

·       Then, topical AA powder (1000mg/ml) was mixed with saline in a small glass dish forming a paste.

·       The mixed slurry paste was applied to the gingival mucosa using for 10 mins.

·       The treated area was left without dressing.

·       Subject were instructed to refrain from drinking acidic or hot beverages for 24hr and to not brush their teeth for 1 day to avoid any mechanical trauma to the gingiva.

·       Each subject will be reviewed for evaluation at four time points.

·       The first tissue evaluation of Micro needling technique will be scheduled before treatment.

·       Clinical examination will be done 1 week after treatment, 2 weeks after treatment & 4 weeks after treatment.

For each patient in Group C subjects were advised to continue only routine oral prophylaxis

 
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