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CTRI Number  CTRI/2024/08/072707 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Hyaluronic acid and vitamin C for thin gingiva 
Scientific Title of Study   Comparative evaluation of microneedling with Hyaluronic acid injection and vitamin C injection in the management of thin gingival phenotype: A Randomised clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandrima Biswas 
Designation  Post Graduate Student 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Department of Periodontics, Room no. 12, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T. Nagar Post, Bengaluru, 560032

Bangalore
KARNATAKA
560032
India 
Phone  8240883516  
Fax    
Email  chandrimafeb23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Umesh Yadalam 
Designation  Professor and Head of Department 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Department of Periodontics, Room no. 12, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T. Nagar Post, Bengaluru, 560032

Bangalore
KARNATAKA
560032
India 
Phone  9844269511  
Fax    
Email  umeshyadalam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chandrima Biswas 
Designation  Post Graduate Student 
Affiliation  Sri Rajiv Gandhi College of Dental Sciences and Hospital 
Address  Department of Periodontics, Room no. 12, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T. Nagar Post, Bengaluru, 560032

Bangalore
KARNATAKA
560032
India 
Phone  8240883516  
Fax    
Email  chandrimafeb23@gmail.com  
 
Source of Monetary or Material Support  
Sri Rajiv Gandhi College of Dental Sciences and Hospital, 3rd Cross Road Post, Chola Nagar, RT Nagar, Bengaluru, Karnataka, India PIN: 560032 
 
Primary Sponsor  
Name  Dr Chandrima Biswas  
Address  Sri Rajiv Gandhi College of Dental Sciences and Hospital, 3rd Cross Road Post, Chola Nagar, RT Nagar, Bengaluru, Karnataka, India, PIN 560032 
Type of Sponsor  Other [Self sponsored] 
 
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 Chandrima Biswas  Sri Rajiv Gandhi College of Dental Sciences and Hospital  Department of Periodontics, Room no. 12, Cholanagar, R. T. Nagar Post, Bengaluru, 560032
Bangalore
KARNATAKA 
8240883516

chandrimafeb23@gmial.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethical Commmittee, Sri Rajiv Gandhi College of Dental Sciences and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Microneedling with Hyaluronic acid injection  Derma pen with 16 pin microneedles will be adjusted with 1.5mm depth at a mode speed of 700 cycles/min used in intermittent motion for microneedling. hyaluronic Acid will be administered using 29 gauge, 5/16 inch and 0.5ml barrel size at 1.5mm depth into the tissue at baseline, 1 week and 2 weeks.  
Intervention  Microneedling with Vitamin C injection  Derma pen with 16 pin microneedles will be adjusted with 1.5mm depth at a mode speed of 700 cycles/min used in intermittent motion for microneedling. Vitamin C will be administered using 29 gauge, 5/16 inch at 0.5ml barrel size at 1.5mm depth into the tissue at baseline, 1 week and 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  18-45 years individuals with no systemic diseases, with thin gingival phenotype less than or equal to 1.5mm and presence of full mouth plaque and gingival index less than 1, with no smoking habits or no malocclusion, crowding, fillings, missing or supernumerary teeth, blood-bone conditions should be absent, presence of minimum of 20 natural teeth 
 
ExclusionCriteria 
Details  Patients undergoing active orthodontic treatment,
under antibiotics in the past 6 months, who have undergone periodontal therapy in the past 6 months, who are allergic to hyaluronic acid and vitamin C and pregnant and lactating women and who are taking blood thinners or drugs leading to gingival enlargement
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Gingival thickness is measured using Number 15 Endodontic Spreader when inserted transgingivally. Stopper will be used as reference points and exact measurement will be recorded using endo ruler.
2. Keratinised tissue width will be measured from gingival margin to muco gingival junction using UNC 15 probe. 
Baseline, 45 days, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival index score (Loe and Silness) and Plaque index score (Silness and Loe)  baseline, 45 days and 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   02/09/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Thick gingiva is usually associated with wide zones of keratinized tissue and flat gingival contour, whereas thin gingiva is associated with a narrow band of keratinized tissue, and a scalloped gingival margin. The periodontal phenotype as a definition is the combination of gingival phenotype and bone morphotype (buccal bone plate thickness). Gingival phenotype involves gingival thickness (GT) and keratinized tissue width (KTW). Thin phenotypes are more vulnerable to injury and likely to induce gingival recession than thick phenotypes because thin gingiva can have an effect on plaque-related inflammatory lesions, making it prone to tissue destruction. Numerous applications, including non-surgical periodontal therapy, mucogingival therapy, guided tissue regeneration (GTR), and implant dentistry, have shown evidence of impact of gingival thickness. Patients with gingiva less than 1.5 mm thick experienced attachment loss after non-surgical periodontal therapy, whereas no attachment loss was seen at sites with gingiva over 2 mm thick. A significant moderate correlation occurred between a critical gingival thickness threshold of >1.1 mm and weighted mean root coverage and weighted complete root coverage according to a systematic review and meta-analysis. Thin gingival thickness of less than 2 mm is associated with slightly greater initial peri-implant bone loss around implants compared with thick gingival thickness for securing the supra crestal tissue attachment of the gingiva. Thus, the presence of soft tissues with a thickness >2.0 mm around implants is crucial in preserving healthy peri-implant tissues and preventing alveolar bone loss through the biological protection. Based on these findings, surgical procedures like gingival tissue augmentation have been proposed to increase gingival thickness to maintain the biologic width and minimize alveolar bone loss. However, postoperative complications, such as uncontrolled bleeding, pain, and infection of the palatal donor site, limit its establishment as a routine procedure. To avoid these complications, new methods are being studied.

Hyaluronic acid (HA), a naturally occurring polysaccharide, is considered an important component of the extracellular matrix in connective tissues of the human body. HA participates in various physiologic and structural processes that preserve tissue integrity, such as cellular and extracellular interactions, modulation of the inflammatory process, interactions with growth factors, tissue healing, collagen synthesis, regulation of the osmotic pressure, and tissue lubrication.

Vitamin C is a proven anti-inflammatory agent and also exerts a reducing and antioxidant effect, scavenges free radicals, and acts as an enzyme cofactor in cells. This nutrient is considered to be an important dietary oxidant for periodontal health, as it plays a crucial role in preventing and slowing the progression of periodontal disease by inducing the differentiation of periodontal ligament progenitor cells. Vitamin C has a very important role in collagen biosynthesis (collagen type I), as it helps in fibroblasts proliferation. It reduces the potentiality of scarring via inhibiting cross-linking of collagen fibers and fibrosis. It acts as a cofactor in hydroxyproline synthesis to produce collagen type IV and improves endothelial cell vitality and function. Vitamin C and Hyaluronic acid promote growth of tissues and wound healing by inducing synthesis of fibroblasts, collagen, elastin and growth factors which can effect gingival thickness and width of keratinised tissue.

Microneedling (MN) is also known as “percutaneous collagen induction therapy". Microinjuries created by MN result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors, such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors are released. In MN, the tissue responds as if experiencing tissue trauma and the body’s own collagen production is induced to preserve skin integrity. Growth factors are released immediately after injury, inducing the proliferation of new cells, and fibroblasts are transformed into collagen and elastin fibers from day 5 up to week 8. Fibroblasts produce collagen and elastin fibers by migrating to the point of intrusion for wound closure. Newly formed fibers thicken the tissue during a process is known as neocollagenesis. Fibroblasts also trigger neoangiogenesis by stimulating the proliferation of endothelial cells in the vessels. However there is very limited literature on microneedling and comparing the effects of Vitamin C and Hyaluronic acid on thin gingival phenotype. So this study will be  conducted to evaluate and compare the effects  of microneedling with hyaluronic acid injection and Vitamin C injection in the management of thin gingival phenotype.

 

 
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