Effect of Water Flossing on Gingival Inflammation Around Single Implants

Effect of Water Flossing on Gingival Inflammation Around Single Implants: Randomized Clinical Trial

This study aims to evaluate the effect of water floss in reversing peri- implant mucositis around dental implants

Study Overview

• Status: Not yet recruiting
• Conditions: Peri Implant Mucositis
• Intervention / Treatment: Device: Water flosser; Device: Tooth brush and string floss

Detailed Description

Patients will be assigned for two clinical appointments, the first visit is for baseline charting, probing depth will be recorded on six sites per implant, using a standardized periodontal probe and the presence or absence of bleeding will be recorded. Disclosing tablets will be utilized to

Confirm the presence or absence of plaque around teeth and the implant. Patients (Group A) will be given a water floss, with verbal and written instructions to use the water floss, twice daily for 2 minutes, along with brushing, while Group B will be instructed to brush with a manual brush alone, twice daily for 2 minutes. After two weeks, in the second visit, the implant site is re-evaluated to monitor the outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amal Jamjoom, BDS, MS; Phone Number: +966500190435; Email: agjamjoom@kau.edu.sa
• Study Contact Backup: Name: Amal G Jamjoom, MS; Phone Number: 0500190435; Email: agjamjoom@kau.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age or older
• Medically cleared
• Have at least one implant-supported crown.

Exclusion Criteria:

1. Smoking
2. Any systemic or localized illness that would interfere with dental implant therapy
3. On medications
4. Pregnancy
5. History of periodontitis/ or peri-implant disease
6. Poor oral hygiene
7. Probing depth is >5

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water flosser; The use of a water flosser+ brushing around implants with mucositis	Device: Water flosser; Water irrigation device
Active Comparator: Control; Brushing and using the string floss.	Device: Tooth brush and string floss; The control group will use the toothbrush and the regular string floss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on Probing	The disappearance of bleeding upon probing with the University of North Carolina-15 mm (UNC-15) periodontal probe. It is done at the same time as probing the pocket depths. It is done at six sites per implant-presence of bleeding = 1, absence = 0 -at each site.	2 and 4 weeks
Plaque Index of Silness and Loe	Score Description 0 No plaque 1 A thin film of plaque adhering to the free gingival margin and adjacent area of the implant; not visible to the naked eye but detectable by probe 2 Moderate accumulation of soft deposits visible to the naked eye within the gingival pocket and/or on the implant and gingival margin | 3 Abundant soft matter within the gingival pocket and/or on the implant and gingival margin |	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depths (PPD)	The PPD will be recorded at baseline visit using the UNC-15 periodontal probe, at 2 weeks, and at 4 weeks. Pocket depths around implants should usually be around 1-4 mm. Pockets that are deeper than 4 mm or are 4 mm or less but with bleeding will be recorded as abnormal.	4 weeks

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Amal G Jamjoom, King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Mucositis; Water flosser; Peri- implant; Water irrigation
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Mucositis; Dentistry; Preventive Dentistry; Oral Hygiene; Toothbrushing
• Other Study ID Numbers: 129-11-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to de-identified individual participant data will be granted to qualified researchers who submit a scientifically sound proposal outlining the research objectives and planned analyses. Requests will be reviewed by the principal investigator to ensure alignment with the original study aims, ethical approval, and data protection requirements. Approved applicants will be required to sign a data use agreement prior to data release. Data will be provided in a secure, de-identified format and used solely for the approved purpose.
• IPD Sharing Time Frame: IPD will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years thereafter.
• IPD Sharing Access Criteria: Requests for access to the IPD should be directed to the corresponding author. Data will be shared in a secure format following approval of the request and execution of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No