Hyaluronic Acid for Residual Periodontal Pockets Adjunctive Treatment
NCT04702334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2021-01-08
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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