Hyaluronic Acid in Papillary Reconstruction

NCT02876276 | Completed Phase 4

• 1 other identifier: 02_D012_36683
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Interdental Papillary Reconstruction

Outcome Measures

Primary Outcomes (2)

• the papillary recession reduction (pRecRed).

  . papillary recession depth (distance from the contact point to gingival margin was measured to the nearest millimeter- CP -GM)

  6 month

• percentage papillary coverage(PPC

  The formula used to calculate the percentage papillary coverage was as follows- Baseline (CP-GM) - 6 month (CP-GM) \---------------------------------------------- x 100 Baseline (CP-GM)

  6 month

Study Arms (2)

HA filler group

ACTIVE COMPARATOR

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

saline filler group

PLACEBO COMPARATOR

with saline same protocol was performed as mentioned in test group

Procedure: Hyaluronic acid filler

Interventions

Hyaluronic acid filler PROCEDURE

Papillary augmentation with HA dermal fillers was considered as the test group

HA filler group; saline filler group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 23, 2016
• Study Start: November 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 23, 2016

Record last verified: 2016-08