Oral Hygiene Tools for Biofilm Removal Around Implants

NCT06697210 | Completed

• 1 other identifier: PER-ECL-2019-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to determine which interproximal hygiene device is most effective at eliminating dental plaque on implants. The main questions to be answered are: Which interproximal hygiene device is most effective in reducing dental plaque (dental floss, superfloss, irrigator, or interproximal brush)? The researchers will compare the different devices using a plaque disclosing agent and standardized photography. Participants: Participants will attend a visit where the screw-retained crown will be removed, and the subgingival area will be stained with a plaque disclosing agent. The first photograph will be taken, and then the crown will be replaced. Subsequently, one of the four methods will be used randomly. The crown will be removed again, and a second photograph will be taken.

Conditions

Healthy; Hygiene; Biofilm Removal

Keywords

dental implants; interproximal hygiene; dental superfloss; oral irrigator; interproximal brushes; plaque reduction; biofilm

Outcome Measures

Primary Outcomes (1)

• Biofilm reduction

  In the first photograph, the total area within the drawn margin was calculated.Subsequently, the erythrosine-coloured area was delimited, determining the biofilm percentage (Pre-area). In the second picture, the residual stained area (Post-area) was calculated in the same way. The percentage reduction of plaque between the two images was then calculated

  Immediate Post-Treatment Evaluation: Directly after the treatment is completed to assess immediate effects.

Study Arms (4)

• Dental Floss (Vitis®, Dentaid, Barcelona, Spain).

ACTIVE COMPARATOR

dental floss is used as interproximal hygiene device. The intervention includes thorough instruction on the correct flossing technique around dental implants to ensure effective removal of plaque and debris. Participants will be supplied with dental floss and given detailed guidance on integrating flossing into their daily oral hygiene regimen. The effectiveness of this method will be evaluated by measuring plaque levels before and after the intervention.

Device: • Dental Floss (Vitis®, Dentaid, Barcelona, Spain).

• Superfloss (Oral B®, Procter & Gamble, USA)

ACTIVE COMPARATOR

superfloss is used as the primary interproximal hygiene device. Superfloss is designed to clean around dental implants, bridges, and wide spaces between teeth. Participants will receive instructions on how to effectively use superfloss, which includes its unique combination of foam, regular floss, and spongy material to remove plaque and debris. The intervention will focus on demonstrating the proper technique to ensure optimal cleaning. The effectiveness of this method will be evaluated by comparing plaque levels before and after the intervention.

Device: • Superfloss (Oral B®, Procter & Gamble, USA)

• Oral irrigator (Waterpick®, Water Pik, Inc., CO., USA)

ACTIVE COMPARATOR

oral irrigator used as the primary interproximal hygiene device. The oral irrigator delivers a stream of pulsating water to help remove plaque and food particles from around dental implants and between teeth. Participants will receive guidance on how to properly use the oral irrigator, including the appropriate pressure settings and angles for effective cleaning. The intervention aims to enhance oral hygiene by providing a thorough rinse of the interproximal areas. The effectiveness of this method will be assessed by comparing plaque levels before and after the intervention.

Device: • Oral irrigator (Waterpick®, Water Pik, Inc., CO., USA)

• Interproximal brushes (Interprox®, Vitis, Dentaid, Spain)

ACTIVE COMPARATOR

interproximal brush is used as the primary interproximal hygiene device. The interproximal brush is specifically designed to clean between teeth and around dental implants, effectively removing plaque and debris in areas that traditional toothbrushes may miss. Participants will receive instructions on how to select the appropriate brush size and how to use it effectively to ensure optimal cleaning. The intervention will emphasize the importance of thorough brushing technique for maintaining oral health. The effectiveness of this method will be evaluated by comparing plaque levels before and after the intervention.

Device: • Interproximal brushes (Interprox®, Vitis, Dentaid, Spain)

Interventions

• Dental Floss (Vitis®, Dentaid, Barcelona, Spain). DEVICE

Dental Floss: A piece of dental floss approximately 40-50 cm in length was taken and placed between the index and middle fingers of each hand, leaving about 2-3 cm free in the middle. The floss was then inserted, embracing the mesial and distal surfaces, and moved up and down three times on each side

• Dental Floss (Vitis®, Dentaid, Barcelona, Spain).

• Superfloss (Oral B®, Procter & Gamble, USA) DEVICE

Superfloss: The stiffened end was used to introduce the thread and the spongy-floss into the interproximal area on both the mesial and distal parts, and a gentle back-and-forth motion was applied to remove bacterial plaque. The spongy-floss was then pulled through to the regular floss section and gently slid under the gumline, followed by an up-and-down motion. These movements were repeated three times on each side.

• Superfloss (Oral B®, Procter & Gamble, USA)

• Oral irrigator (Waterpick®, Water Pik, Inc., CO., USA) DEVICE

Oral Irrigator: The finest tip was selected and placed in the mesiobuccal, distobuccal, mesiolingual, and distolingual interproximal spaces. The irrigator was activated at medium power (2/3), and the process was repeated three times on each side for five seconds.

• Oral irrigator (Waterpick®, Water Pik, Inc., CO., USA)

• Interproximal brushes (Interprox®, Vitis, Dentaid, Spain) DEVICE

Interproximal Brush Group: According to the interproximal space, the appropriate size was selected for each case. The brush was then placed horizontally in the interproximal space mesially and distally, and a back-and-forth movement was performed three times on each side.

• Interproximal brushes (Interprox®, Vitis, Dentaid, Spain)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontally healthy patients with at least one single screw-retained implant-supported crown (loaded for more than one year) on a molar or premolar site with neighboring teeth were recruited. The implants had to present ≤ 4 mm of probing pocket depth and have an appropriate prosthetic design that allowed for proper oral hygiene.

You may not qualify if:

• Drug consumption that could cause gingival enlargement, such as phenytoin, cyclosporin, and/or calcium channel blockers.
• Presence of uncontrolled diabetes mellitus. Smokers. Presence or signs of peri-implant diseases or uncontrolled periodontal disease. Prosthetic design that did not allow for proper interproximal hygiene (determined by using the smallest size of interproximal brush).

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (5)

• Slot DE, Valkenburg C, Van der Weijden GAF. Mechanical plaque removal of periodontal maintenance patients: A systematic review and network meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:107-124. doi: 10.1111/jcpe.13275.

  PMID: 32716118 BACKGROUND

• Sirinirund B, Siqueira R, Li J, Mendonca G, Zalucha J, Wang HL. Effects of crown contour on artificial biofilm removal efficacy with interdental cleaning aids: An in vitro study. Clin Oral Implants Res. 2023 Aug;34(8):783-792. doi: 10.1111/clr.14105. Epub 2023 Jun 3.

  PMID: 37269176 BACKGROUND

• Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.

  PMID: 30968949 BACKGROUND

• Pons R, Nart J, Valles C, Salvi GE, Monje A. Self-administered proximal implant-supported hygiene measures and the association to peri-implant conditions. J Periodontol. 2021 Mar;92(3):389-399. doi: 10.1002/JPER.20-0193. Epub 2020 Aug 18.

  PMID: 32761897 BACKGROUND

• van Velzen FJ, Lang NP, Schulten EA, Ten Bruggenkate CM. Dental floss as a possible risk for the development of peri-implant disease: an observational study of 10 cases. Clin Oral Implants Res. 2016 May;27(5):618-21. doi: 10.1111/clr.12650. Epub 2015 Aug 11.

  PMID: 26261052 RESULT

MeSH Terms

Interventions

Dental Devices, Home Care

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies

Study Officials

• Andres Pascual La Rocca, PhD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS , PhD, Professor

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 20, 2024
• Study Start: April 11, 2019
• Primary Completion: September 21, 2023
• Study Completion: April 23, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

ES (1)