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Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

Primary Purpose

Peri-implant Mucositis, Mucositis Oral

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Application NaOCl gel + HA gel
Non-surgical mechanical debridement
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring Hyaluronic Acid, Peri-implant mucositis, Sodium hypochlorite

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 18 years; Non-smokers and smokers ( ≤ 10 cigarettes/day); Presence of at least 1 implant in mucositis, clinically and radiographically detected; The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed. Exclusion Criteria: Cancer patients; Uncontrolled diabetic patients; Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months; Pregnant or breastfeeding patients; Implants that support mobile prosthetic products; Implants in peri-implantitis, detected clinically and radiographically.

Sites / Locations

  • Semmelweis UniversityRecruiting
  • University of Naples Federico IIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NaOCl + HA Group

NSMD Group

Arm Description

A NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle.

Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.

Outcomes

Primary Outcome Measures

Change of BoP (+/-)
Bleeding on periodontal probing

Secondary Outcome Measures

Change of Full-mouth Plaque Score (FMPS; %)
Percentage of all sites exhibiting plaque
Change of Full-mouth Bleeding Score (FMBS; %)
Percentage of all sites exhibiting bleeding
Change of Probing Depth (PD; millimeters).
Distance from the gingival margin to the bottom of the peri-implant pocket

Full Information

First Posted
June 22, 2023
Last Updated
July 13, 2023
Sponsor
Federico II University
Collaborators
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT05926297
Brief Title
Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
Official Title
Treatment of Peri-implant Mucositis by Non-surgical Debridement and Adjunctive Application of a Combination of Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
Collaborators
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up. After a meticulous selection, patients will be randomly assigned to Test (Sodium Hypochlorite-based gel + NSMD + Hyaluronic Acid-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.
Detailed Description
The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (NaOCl gel) and a cross-linked hyaluronic acid-based gel (HA gel) as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up (Clean & Seal concept). Following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to Test NaOCl-based gel + NSMD + HA-based gel) or Control (NSMD) group. Patients will be recruited at Department of Periodontology (Univeristy of Naples "Federico II") and at Department of Periodontology (University of Budapest "Semmelweis"). Subsequently, after recording of the clinical parameters (BoP, FMPS, FMBS, PD), in the Test group a NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. Conversely, Control group will be treated only through the NSMD. All clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again after 6 months for the final evaluation. Data analysis will be performed using statistical software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis, Mucositis Oral
Keywords
Hyaluronic Acid, Peri-implant mucositis, Sodium hypochlorite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with NaOCl-based gel + NSMD + HA-based gel in Test group and with NSMD alone in Control group. All clinical parameters will be recorded and the final evaluation will be performed.
Masking
Participant
Masking Description
Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NaOCl + HA Group
Arm Type
Experimental
Arm Description
A NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle.
Arm Title
NSMD Group
Arm Type
Active Comparator
Arm Description
Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.
Intervention Type
Procedure
Intervention Name(s)
Application NaOCl gel + HA gel
Intervention Description
First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel
Intervention Type
Procedure
Intervention Name(s)
Non-surgical mechanical debridement
Intervention Description
Only mechanical debridement with curettes ans scaler tips
Primary Outcome Measure Information:
Title
Change of BoP (+/-)
Description
Bleeding on periodontal probing
Time Frame
baseline, 6 months after periodontal therapy
Secondary Outcome Measure Information:
Title
Change of Full-mouth Plaque Score (FMPS; %)
Description
Percentage of all sites exhibiting plaque
Time Frame
baseline, 6 months after periodontal therapy
Title
Change of Full-mouth Bleeding Score (FMBS; %)
Description
Percentage of all sites exhibiting bleeding
Time Frame
baseline, 6 months after periodontal therapy
Title
Change of Probing Depth (PD; millimeters).
Description
Distance from the gingival margin to the bottom of the peri-implant pocket
Time Frame
baseline, 6 months after periodontal therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; Non-smokers and smokers ( ≤ 10 cigarettes/day); Presence of at least 1 implant in mucositis, clinically and radiographically detected; The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed. Exclusion Criteria: Cancer patients; Uncontrolled diabetic patients; Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months; Pregnant or breastfeeding patients; Implants that support mobile prosthetic products; Implants in peri-implantitis, detected clinically and radiographically.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it
First Name & Middle Initial & Last Name or Official Title & Degree
Péter Windisch
Phone
318-5222
Email
parodontologia@dent.semmelweis-univ.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Ramaglia
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University
City
Budapest
State/Province
HU
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Péter Windisch
Phone
318-5222
Email
parodontologia@dent.semmelweis-univ.hu
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Ramaglia
Phone
+393476912911
Email
luca.ramaglia@unina.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

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