None listed
Conditions
Brief summary
The Global Burden of Disease Study of 2016 revealed that periodontal disease ranked as the 11th most widespread condition globally (Vos et al. 2017), affecting approximately 20% to 50% of the population (Baehni et al. 2010). Gingivitis is a reversible gingival inflammation caused by the accumulation of dental plaque at the gingival margin and may lead to occasional gingival bleeding (Armitage 2004). The mode of administration of local drug delivery is crucial in the oral cavity, besides the convenience of application, the drug-eluting material must remain stable under the persistent fluid flow (saliva) and withstand cyclic stresses caused by chewing activity. A Leptospermum scoparium essential oil-containing emulsion designed for application into the periodontal pocket can increase the substantivity and stabilize the essential oil (Porter et al. 2021). The aim of this study is to evaluate the effectiveness of a locally applied hydrogel containing Manuka oil on experimentally induced gingivitis. 66 healthy 4th year dental students will be recruited. An intraoral scanning of the upper posterior teeth will be taken to fabricate a mouthguard. Participants receive professional tooth cleaning prior to the start of the trial, and then cease brushing their upper right teeth for 21 days. Gum inflammation will be measured weekly throughout the study. After 21 days, with gum inflammation established, the participants will then commence using the control or test medicament gels. The experimental group will be given the test medication, a methyl-cellulose gel containing Manuka oil microspheres. They will be asked to self-administer approximately 1.0g of the gel twice daily to the upper right posterior teeth by expressing the gel into the customised mouthguard and wearing this for 2 minutes. The positive control group will follow the same protocol but will use a commercially-available 0.5% chlorhexidine gel. The negative control group will follow the same protocol but will use a methyl-cellulose gel with no active ingredients. Oral hygiene instructions will be given to all participants. Participants will be examined at baseline then once every week for 6 weeks. All 7 examinations (Days 1, 7,14, 21, 28, 35, 42) will include the recording of clinical parameters: gingival index (GI) plaque index (PlI) probing pocket depth (PPD) and gingival bleeding index (GBI). The colour of the teeth and of the gingiva will be recorded and the gingiva crevicular fluid (GCF) and dental plaque samples will be collected at baseline, on Day 21 and Day 42. On day 42, participants will be given a questionnaire with a visual analogue scale (VAS) to assess their opinions on the gel. After the clinical trial, all subjects resume their normal oral hygiene procedures and will be reviewed once a month until the gingival clinical parameters return to the baseline.
Interventions
This is an experimental gingivitis trial. The participants will receive gum health examination and a 20-minute professional cleaning at baseline and have to cease brushing and routine oral hygiene on 3-4 teeth of interest at the upper right side for 21 days to induce gingivitis. The gum health examination includes the following:
1. An assessment of gum redness and swelling (Gingival Index)
2. An assessment of plaque present on the study teeth (Plaque index)
3. The gap between gum and tooth (Peri
This is an experimental gingivitis trial. The participants will receive gum health examination and a 20-minute professional cleaning at baseline and have to cease brushing and routine oral hygiene on 3-4 teeth of interest at the upper right side for 21 days to induce gingivitis. The gum health examination includes the following: 1. An assessment of gum redness and swelling (Gingival Index) 2. An assessment of plaque present on the study teeth (Plaque index) 3. The gap between gum and tooth (Periodontal Probing Depth) 4. Assessment of gum bleeding (Gingival bleeding index) 5. Photograph of teeth to determine color of teeth and gums 6. Collection of the gum fluid and plaque samples Participants will be reviewed every week for 3 weeks prior to the establishment of experimental gingivitis. On day 21, after experimental gingivitis has been established, all participants will receive a 20-minute professional cleaning after gum health examination. On the same appointment, the experimental group will be given the test medication, a carboxymethyl-cellulose gel containing manuka oil microspheres. They will be asked to self-administer approximately 1.0g of the gel twice daily, after toothbrushing, to the upper right posterior teeth by expressing the gel into the customised mouthguard and wearing this for 2 minutes. They will be asked to administer the gel for 3 weeks and gum health examination will be performed every week for 3 weeks. All participants will be involved in a split mouth study design, comparing the gum health on the upper left (without gingivitis) and upper right (with induced gingivitis). Gum health examination will take place once every week for a total of 8 visits. Approximately 30 minutes will be required for each examination. The examination will be conducted by a registered dentist. Adherence to intervention will be monitored in the dental undergraduate class which all the volunteers attend by recording responses in the attendance sheet.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Dental students in good health with at least 3 maxillary posterior teeth (premolar and molars) on each side, free of periodontal pockets of >3mm
Exclusion criteria
Have periodontitis or peri-implantitis, active dental caries, active infection in the oral cavity, had a history of allergy to honey or chlorhexidine products, had antibiotics or chlorhexidine mouthwash recently, wears a partial plate replacing upper teeth, undergoing orthodontic treatment, currently pregnant or nursing, a smoker or vaper.
Outcome results
None listed