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This study aims to evaluate the effect of water floss in reversing peri- implant mucositis around dental implants
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water flosser | Experimental | The use of a water flosser+ brushing around implants with mucositis |
|
| Control | Active Comparator | Brushing and using the string floss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water flosser | Device | Water irrigation device |
| |
| Tooth brush and string floss |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal Jamjoom, BDS, MS | Contact | +966500190435 | agjamjoom@kau.edu.sa | |
| Amal G Jamjoom, MS | Contact | 0500190435 | agjamjoom@kau.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Amal G Jamjoom | King Abdulaziz University | Principal Investigator |
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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 will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years thereafter.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2026 | Jan 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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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.
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| Device |
The control group will use the toothbrush and the regular string floss. |
|
| D009057 |
| Stomatognathic Diseases |