NCT07364916

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

December 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 13, 2025

Last Update Submit

January 18, 2026

Conditions

Peri Implant Mucositis

Keywords

Peri- implantMucositisWater irrigationWater flosser

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Probing Pocket Depths (PPD)

    4 weeks

Study Arms (2)

Water flosser

EXPERIMENTAL

The use of a water flosser+ brushing around implants with mucositis

Device: Water flosser

Control

ACTIVE COMPARATOR

Brushing and using the string floss.

Device: Tooth brush and string floss

Interventions

Water flosserDEVICE

Water irrigation device

Water flosser
Tooth brush and string flossDEVICE

The control group will use the toothbrush and the regular string floss.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Smoking
  • Any systemic or localized illness that would interfere with dental implant therapy
  • On medications
  • Pregnancy
  • History of periodontitis/ or peri-implant disease
  • Poor oral hygiene
  • Probing depth is \>5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mucositis

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Amal G Jamjoom

    King Abdulaziz University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Jamjoom, BDS, MS

CONTACT

+966500190435agjamjoom@kau.edu.sa

Amal G Jamjoom, MS

CONTACT

0500190435agjamjoom@kau.edu.sa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups of implant patients will be randomly allocated to one of 2 interventions; one group will brush only. The other group will brush and use the water flosser around the implant with mucositis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor at KAU

Study Record Dates

First Submitted

December 13, 2025

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
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.