| CTRI Number |
CTRI/2025/09/094611 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study on gum fillers for closing gaps between teeth in different gum conditions |
|
Scientific Title of Study
|
Reconstruction of interdental papilla using hyaluronic acid gingival fillers: A comparative approach in thick and thin gingival phenotypes-A 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 |
Dr Pallavi Holal |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode:574327
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8073208018 |
| Fax |
|
| Email |
pallaviholal9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivananda H |
| Designation |
Associate Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode:574327
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9900794769 |
| Fax |
|
| Email |
shivanand_perio@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivananda H |
| Designation |
Associate Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode:574327
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9900794769 |
| Fax |
|
| Email |
shivanand_perio@yahoo.co.in |
|
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Source of Monetary or Material Support
|
| KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Pallavi Holal |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode:574327 |
| Type of Sponsor |
Other [Self] |
|
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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 Pallavi Holal |
KVG Dental College and Hospital |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode:574327 Dakshina Kannada KARNATAKA |
8073208018
pallaviholal9@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Dental College 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: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyaluronic acid 0.2 ml |
0.2 ml of hyaluronic acid is injected in interdental area. Patient is recalled after 3 weeks and injected again (if necessary).Patient is recalled after 3 months and injected if necessary. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Systematically healthy patient.
2.Patient aging between 18-35
3.Good oral hygiene.
4.Periodontal pocket less than or equal to 4mm.
5.No radiographic evidence of interdental bone loss.
6.Patient who have agreed to participate in the study.
7.The respective teeth should be free from caries with no fixed prosthesis or orthodontic appliance. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactacting mothers
2. Tobacco users and alcoholics
3.Patients with systemic condition/disease.
4. Known allergy of Hyaluronic acid.
5.Fixed orthodontic appliances.
6. Tooth mobility
7. Consumption of drugs causing gingival hyperplasia.
8.Interdental bone loss.
9.Inadequate attached gingiva on study teeth. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the patient reported outcomes after Hyaluronic acid gel application in thick and thin gingival phenotypes. |
Baseline, 3 weeks, 3 months, 6 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of Hyaluronic acid gel in enhancing interdental papilla in thick and thin gingival phenotypes.
2. To compare the effectiveness of Hyaluronic acid gel in enhancing interdental papilla fill in thick and thin gingival phenotypes.
3. To evaluate patient reported outcomes after Hyaluronic acid gel application in thick and thin gingival phenotypes. |
Baseline, 3 weeks, 3 months, 6 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 2 |
|
Date of First Enrollment (India)
|
18/11/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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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
|
The interdental papilla is a part of the gingival tissue that fills the space between teeth, known as the gingival embrasure located just beneath the area where the teeth come into contact. It is gingival tissue that is keratinized and covered by stratified squamous epithelium. In the case of anterior teeth the interdental papilla usually has a pyramidal shape, while in posterior teeth, it adopts a more col shaped form. The facial and lingual surfaces gradually taper towards the interproximal contact area, while the mesial and distal surfaces exhibit a slight concavity. The form, location, and existence of the interdental papilla are influenced by the underlying alveolar bone, the proximal contact point, and the approximal area of adjacent teeth. Cohen was the first to describe its morphologyThe papillae in the maxillary anterior region plays an important role in dental aesthetics. An open gingival embrasure can lead to various complications, including food impaction, increased plaque buildup, reduced self-cleansing ability, and a higher risk of periodontal disease2. The absence of papilla results in a visible gap between teeth, commonly referred to as a black triangle1. Several factors contribute to the formation of black triangles, such as periodontal disease, root angulation, triangular-shaped crowns, improper brushing techniques, aging, tooth loss, and the length of the embrasure area1. Several techniques can be utilized to restore missing gingival papilla, including restorative procedures, orthodontic treatment, interdisciplinary approaches and various surgical augmentation methods4. Among the surgical options, the autogenous subepithelial connective tissue graft is highly recommended due to its superior aesthetics, long-term stability, predictable and reproducible outcomes. However, its major drawback lies in the need for donor site that creates an additional surgical site to harvest the graft, which may reduce patient’s willingness2. There is a greater emphasis on minimally invasive periodontal therapy, as it offers the advantages of faster healing, enhanced aesthetics, minimally invasive, and greater patient compliance2. Hyaluronic acid (HA) is recently used as a gingival filler for the reconstruction of lost interdental papillae1. It is an important part of the structural matrix, HA plays a crucial role in maintaining tissue integrity. Its functions include intercellular communication, relieves pain, faster wound healing, stimulating neovascularization, and helps in collagen synthesis1 .In 2010, Beker et al. were the first to utilize injectable hyaluronic acid (HA) filler for the treatment of papillary recession, demonstrating promising outcomes2. Gingival phenotype refers to the thickness of the gingiva and width of keratinized tissue around the teeth(5). It plays a crucial role in determining the success of various dental treatments ,particularly periodontal procedures such as root coverage techniques and dental implant placement6. Assessing the gingival phenotype before initiating treatment is essential, as different phenotypes respond differently to inflammation, surgical intervention and restorative procedures. Proper evaluation helps improve treatment outcomes and prognosis ,ensuring more predictable and stable results6 . Gingival phenotype are generally categorized into 2 types; thick flat and thin scalloped. When the gingival thickness measures 1.5 mm or more , it is classified as the thick gingival phenotype. In contrast, gingiva measuring less than 1.5 mm in thickness is referred to as thin gingival phenotype.
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