| 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 |
|
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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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
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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
|
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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 |
|
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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
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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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