A Topical Desiccant Agent in Association With Manual Debridement in the Treatment of Peri-implant Mucositis

NCT03858959 | Completed

• 1 other identifier: UVerona
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

In patients presenting peri-implant mucositis, effective sub-mucosal debridement is crucial to prevent peri-implantitis. The aim of this pilot study was to assess the 3-month clinical and microbiological effects of a locally delivered liquid desiccant agent with molecular hygroscopic properties, in association with sub-gingival manual debridement, in sites with peri-implant mucositis. Twenty-three patients presenting at least one implant with no radiographically detectable bone loss, a pocket probing depth ≥ 4 mm and bleeding on probing, were included in a 3-month randomized, parallel-groups, single-blind, prospective study. At baseline (T0), patients were randomly assigned to receive a desiccant liquid agent with molecular hygroscopic properties before debridement (Test-Group), or a Chlorhexidine 1% disinfectant gel after debridement (Control-Group). Treatments were performed also after 7 and 14 days. Peri- implant soft tissues assessment (PPD, BOP, mBI, VPI, mPLI) and microbial sampling were assessed at baseline and at 3-month follow-up (T1).

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (5)

• Pocket probing depth (PPD)

  PPD is recorded in mm as the distance between the gingival margin and the base of the periodontal pocket. The possible scale range is from 1 to 10 mm. The higher is the measure, the worst is the value. The measure is assessed at baseline (T0) and at 3-month recall appointment (T1) using a periodontal probe (Florida Probe; Florida Probes Company, Gainesville, FL, US), applying a force of mild intensity on each of the six sites of the implant, three (mesial, central, distal) on the buccal side and three on the lingual/palatal side.

  2 minutes

• Bleeding on probing (BOP)

  BOP is recorded as 0 (no bleeding) or 1 (yes bleeding) after probing. It is a dichotomous dimensionless index with two possible values (0 and 1). It is assessed at baseline (T0) and at 3-month recall appointment (T1) using a periodontal probe (Florida Probe; Florida Probes Company, Gainesville, FL, US), applying a force of mild intensity on each of the six sites of the implant, three (mesial, central, distal) on the buccal side and three on the lingual/palatal side.

  2 minutes

• Modified Bleeding Index (mBI)

  mBI is recorded as 0, 1, 2, 3 according to Mombelli et al. It is a dimensionless index with four possible values and a scale range from 0 to 3 (3 is the most abundant bleeding and the worst value). It is assessed at baseline (T0) and at 3-month recall appointment (T1) using a periodontal probe (Florida Probe; Florida Probes Company, Gainesville, FL, US), applying a force of mild intensity on each of the six sites of the implant, three (mesial, central, distal) on the buccal side and three on the lingual/palatal side.

  2 minutes

• Modified Plaque Index (mPLI)

  mPLI is recorded as 0, 1, 2, 3 according to Mombelli et al. It is a dimensionless index with four possible values and a scale range from 0 to 3 (3 is the most abundant plaque and the worst value). It is assessed at baseline (T0) and at 3-month recall appointment (T1) using a periodontal probe (Florida Probe; Florida Probes Company, Gainesville, FL, US), applying a force of mild intensity on each of the six sites of the implant, three (mesial, central, distal) on the buccal side and three on the lingual/palatal side.

  2 minutes

• Visible Plaque Index (VPI)

  VPI is recorded as 0 (no plaque) or 1 (yes plaque) after probing. It is a dichotomous dimensionless index with two possible values (0 and 1). It is assessed at baseline (T0) and at 3-month recall appointment (T1) using a periodontal probe (Florida Probe; Florida Probes Company, Gainesville, FL, US), applying a force of mild intensity on each of the six sites of the implant, three (mesial, central, distal) on the buccal side and three on the lingual/palatal side.

  2 minutes

Secondary Outcomes (1)

• Bacterial count (aerobic and anaerobic)

  3 days

Study Arms (2)

HYBENX® Oral Tissue decontaminantTM (HBX)

EXPERIMENTAL

HYBENX® Oral Tissue decontaminantTM is a concentrated aqueous solution of sulfonated aromatics and free sulphates. Once placed onto susceptible organic material, the product instantly absorbs free and electrostatically bonded water, denaturing the molecular structure of the organic matter. Biofilm is expected to be especially sensitive to the disruptive action of HBX solution by virtue of its porous structure and high water content.

Device: topical agent

Chlorhexidine Digluconate CorsodylTM (CHX)

ACTIVE COMPARATOR

Chlorhexidine Digluconate CorsodylTM Dental Gel 1% is an antiseptic gel with cationic nature, effective against a wide range of Gram positive and negative bacteria, favourable to the plaque control and oral inflammation prevention.

Device: topical agent

Interventions

topical agent DEVICE

HBX protocol consisted in product application into the periodontal pocket (starting from the base) with a delivery syringe, second saline solution irrigation after 60 seconds to flush-out the product and Teflon-curettes debridement to remove the deposits. CHX protocol consisted in Teflon-curettes debridement to remove the deposits, associated with a first saline solution irrigation, and product application into the periodontal pocket (starting from the base) with a delivery syringe.

Chlorhexidine Digluconate CorsodylTM (CHX); HYBENX® Oral Tissue decontaminantTM (HBX)

Eligibility Criteria

• Age: 37 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- presence of at least one implant with a pocket probing depth (PPD) ≥ 4 mm, bleeding on probing (BOP) or pus on probing and no radiographically detectable bone loss (Qualifying site).

You may not qualify if:

• pregnant or lactating females;
• patients with severe systemic diseases, or with uncontrolled diabetes mellitus;
• assumption of agents affecting the periodontal status within 1 month prior to the study;
• use of systemic antibiotics within 3 months prior to the study;
• prophylactic antibiotics requirement;
• peri-implant specific treatments within 6 months prior to the study;
• allergy to sulphates and its derivatives.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Giorgio Lombardo

Verona, 37134, Italy

Location

Study Officials

• Giorgio Lombardo

  Università di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 1, 2019
• Study Start: July 1, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 31, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)