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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  
 
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] 
 
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 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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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 
 
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 
 
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 morphology

The 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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