Hyaluronic Acid for Residual Periodontal Pockets Adjunctive Treatment

NCT04702334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-01-08

No results posted yet for this study

Summary

Objective: To evaluate the adjunctive effect of hyaluronic acid (HA) gel in the treatment of residual periodontal pockets over a 12-month period.

Materials and Methods: Periodontal patients enrolled in maintenance and presenting at least one periodontal pocket 5-9 mm of depth in the anterior area were recruited from six university-based centers. Each patient was randomly assigned to control treatment with professional mechanical plaque removal (PMPR) and local placebo application or test treatment with the adjunctive use of HA to PMPR. Clinical parameters \[i.e. probing depth (PD), bleeding on probing (BoP), plaque score, recession (REC), and clinical attachment loss (CAL)\] and microbiological samples for the investigation of the total bacterial count (TBC) and presence of specific bacterial strains (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum) were taken at baseline and every 3 months, until study termination. PD was determined as the primary outcome variable.

Conditions

  • Periodontitis

Interventions

DRUG

Hyaluronic Acid

After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of hyaluronic acid gel for the test group . The tip of blunt application needle mounted on the syringe containing HA was delicately inserted in the pocket until resistance was felt. The injection was performed until the remnants started getting out of the pocket.This adjunctive treatment was performed at baseline and at the 3 months control.

DRUG

Lidocain

After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of anesthetic for the control group. The tip of blunt application needle mounted on the syringe containing HA was delicately inserted in the pocket until resistance was felt. The injection was performed until the remnants started getting out of the pocket.This adjunctive treatment was performed at baseline and at the 3 months control.

Sponsors & Collaborators

  • University of Rijeka

    collaborator OTHER
  • University of Zagreb

    collaborator OTHER
  • Jagiellonian University

    collaborator OTHER
  • Medical University of Sofia

    collaborator OTHER
  • University of Bern

    collaborator OTHER
  • Plovdiv Medical University

    collaborator OTHER
  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Blerina Zeza, DDS,MS,PhD · University of Rome

  • Andrea Pilloni, DDS,Msc · University of Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-11-30
Completion
2018-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04702334 on ClinicalTrials.gov