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Hyaluronic Acid in Papillary Reconstruction

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ClinicalTrials.gov Identifier: NCT02876276
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary:
Hyaluronic acid (HA) has been used as a dermal filler in medicine for many years. It also has umpteen benefits in terms of aiding in rapid healing and resolution of inflammation. Thus in the present study, HA has been used at the test site to fill papillary recession defects. At the control site saline was injected as the placebo.

Condition or disease Intervention/treatment Phase
Interdental Papillary Reconstruction Procedure: Hyaluronic acid filler Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Minimally Invasive Treatment for Papillae Deficiencies in Esthetic Zone Using Hyaluronic Acid
Study Start Date : November 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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Arm Intervention/treatment
Active Comparator: HA filler group
6 weeks after the initial therapy, patients were scheduled for the procedure.16 Local Anesthetic solution (2% Lignocaine HCl with adrenaline 1:80000) was administered.17 About 0.2 ml of a commercially available hyaluronic acid based gel was injected 2-3 mm coronal to the apical tip of the receded interdental papilla . Injections were performed using 23 gauge X 25mm intraoral injection needles . The concentration of HA gel used was 20 mg/ml.6 The area was gently massaged to ensure that the filler was uniformly distributed. Care was taken to fill each papilla to full correction (100% of defect). After the treatment the individual patient syringes were capped and stored in a refrigerator with patient names and details. The needle was discarded. Patients were seen three weeks after the initial treatment and if augmentation was still deemed necessary, another injection of 0.2ml was injected up to three times
Procedure: Hyaluronic acid filler
Papillary augmentation with HA dermal fillers was considered as the test group

Placebo Comparator: saline filler group
with saline same protocol was performed as mentioned in test group
Procedure: Hyaluronic acid filler
Papillary augmentation with HA dermal fillers was considered as the test group




Primary Outcome Measures :
  1. the papillary recession reduction (pRecRed). [ Time Frame: 6 month ]
    . papillary recession depth (distance from the contact point to gingival margin was measured to the nearest millimeter- CP -GM)

  2. percentage papillary coverage(PPC [ Time Frame: 6 month ]

    The formula used to calculate the percentage papillary coverage was as follows-

    Baseline (CP-GM) - 6 month (CP-GM)

    ---------------------------------------------- x 100 Baseline (CP-GM)




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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age group of 25-75 years, with at least one pair of similar bilateral, Nordland's class I and class II loss of interdental papillae in the maxillary anterior region, radiographic evidence of sufficient interdental alveolar bone (i.e. distance between alveolar crest and contact point ≤ 5mm), pocket probing depth ≤ 4mm, systemically healthy patients, patients willing to participate in the study and patients with esthetic concerns

Exclusion Criteria:

  • Patients with known allergy to hyaluronic acid, patients with poor plaque control.(≥20% O'Leary plaque index), medically compromised patients, pregnant and lactating women, history of smoking, who had received a crown or pontic on one or both teeth involved in the interproximal space, interproximal spaces next to teeth that included root grooves, furcations, Miller's tooth mobility index >18, open contacts, probing depths >3 mm, and radiographic evidence of pathology, with translocated or tilted teeth, and who had undergone papillary regeneration procedures in the area selected previously
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Responsible Party: Krishnadevaraya College of Dental Sciences & Hospital
ClinicalTrials.gov Identifier: NCT02876276    
Other Study ID Numbers: 02_D012_36683
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents