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

• ClinicalTrials.gov Identifier: NCT03858959
• Recruitment Status: Completed
• First Posted: March 1, 2019
• Last Update Posted: March 1, 2019
• Sponsor: Universita di Verona
• Information provided by (Responsible Party): Giorgio Lombardo, Universita di Verona

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Peri-implant Mucositis	Device: topical agent	Not Applicable

Detailed Description:

A single-center, single-masked, parallel-groups, randomized clinical and microbiological study, was conducted between July and October 2018 at the Dentistry and Maxillo-facial Surgery Clinic, Department of Surgery, Dentistry, Paediatrics and Gynaecology (DIPSCOMI), University of Verona, Verona, Italy. The experimental protocol (Protocol HX-GL-ITA13, approval date 20/11/2013) was approved by the Ethical Committee of the University of Verona. The study was conducted in accordance with the Ethical Principles of the 64th World Medical Association Declaration of Helsinki and was consistent with good clinical practices. All participants signed a written informed consent.

The subjects were enrolled among individuals examined through a survey on prevalence of peri- implant infections (mucositis and peri-implantitis) in single-crown plateau-design locking-taper implants with a 3-year follow-up period. Twenty-three patients, aged between 37 and 71 years, met the study criteria.

Patients were randomly assigned (using a predefined computer-generated randomization scheme) to the Test-Group, which received the administration of a desiccant liquid with molecular hygroscopic properties (HYBENX® Oral Tissue decontaminantTM, HBX) before SRP, or to the Control-Group, which received the administration of a disinfectant gel after SRP (Chlorhexidine Digluconate CorsodylTM Dental Gel 1%, CHX).

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. 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. On the Test-Group of this study, HBX was administered before the Teflon-curettes debridement and left in contact with supra and sub-gingival plaque biofilm for up to 60 seconds, then rinsed with water and evacuated.

At baseline (T0) subjects were randomly assigned to the Test-Group or to the Control-Group, in order to be examined for microbial sampling, peri-implant soft tissues assessment and radiographic bone levels. The implants were consequently treated with HBX, before a SRP professional session, or CHX, after a SRP professional session. The treatment, performed by the same operator, was then repeated on days 7 and 14.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Topical Desiccant Agent in Association With Manual Debridement in the Initial Treatment of Peri-implant Mucositis: a Clinical and Microbiological Pilot Study
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: October 25, 2018
• Actual Study Completion Date: October 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: HYBENX® Oral Tissue decontaminantTM (HBX); 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; 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.
Active Comparator: Chlorhexidine Digluconate CorsodylTM (CHX); 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Pocket probing depth (PPD) [ Time Frame: 2 minutes ]
   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. Bleeding on probing (BOP) [ Time Frame: 2 minutes ]
   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.
3. Modified Bleeding Index (mBI) [ Time Frame: 2 minutes ]
   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.
4. Modified Plaque Index (mPLI) [ Time Frame: 2 minutes ]
   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.
5. Visible Plaque Index (VPI) [ Time Frame: 2 minutes ]
   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.

Secondary Outcome Measures :

1. Bacterial count (aerobic and anaerobic) [ Time Frame: 3 days ]
   The concentration of bacteria in the plaque is expressed as CFU / mg of plaque. After supra-gingival plaque removal, the deepest site was isolated with sterile cotton rolls in order to properly collect a plaque sample (1 mg ca), through two paper points inserted and left for 30 seconds at the base of the periodontal pocket. The collected plaque sample was put in an Eppendorf tube containing thioglycolate medium (BD Difco) for cultural investigations.Plates were incubated at 37°C for 48 hours under specific conditions (Columbia blood agar and Schaedler blood agar). Colonies that appeared were counted and results refer to CFU/mg (colony-forming units per mg of plaque).

Eligibility Criteria

• Ages Eligible for Study: 37 Years to 71 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Italy

Giorgio Lombardo

Verona, Italy, 37134

Sponsors and Collaborators

Universita di Verona

Investigators

• Principal Investigator: Giorgio Lombardo; Università di Verona

More Information

• Responsible Party: Giorgio Lombardo, Associate Professor, Universita di Verona
• ClinicalTrials.gov Identifier: NCT03858959
• Other Study ID Numbers: UVerona
• First Posted: March 1, 2019
• Last Update Posted: March 1, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Mucositis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases