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Non-surgical treatments for disease of the gum surrounding dental implants

Comparison of non-surgical treatments of peri-implant disease. Clinical and microbiological assessment in a two-factor randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13724605
Enrollment
64
Registered
2019-09-18
Start date
2016-03-09
Completion date
Unknown
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implantitis at a dental implant Oral Health Peri-implantitis at a dental implant

Interventions

All of the patients underwent debridement with ultrasonic dedicated scalers at the dental implant. The two studied factors are: 1. Glycine powder: Abrasive powder amino acid glycine

Sponsors

Clinica Merli
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or older 2. Suffering from initial to moderate peri-implantitis at an implant site 3. Presence of at least one screw-type titanium implant exhibiting signs of moderate peri-implantitis: maximum probing depth from 5 to 8 mm bleeding on probing or suppuration in at least one site, and radiographic bone loss in at least one site 4. Radiographic infraosseous component of the defect = 5mm 5. Radiographic suprabony component of the defect = 4mm 6. Presence of at least 2 mm of keratinized mucosa 7. Implant loading of at least 6 months

Exclusion criteria

Exclusion criteria: 1. Patients incapable of giving informed consent 2. Mobile implant 3. Head and neck irradiated patient 4. Chemo or immunosuppressive therapy over the previous 5 years 5. Treatment with intravenous amino-bisphosphonates 6. Poor oral hygiene and motivation 7. Untreated periodontitis 8. Uncontrolled diabetes 9. Pregnancy and lactating period 10. Substance abusers 11. Allergy to chlorhexidine or phenolic or sulfur compounds 12. Smoking more than 20 cigarettes per day, or the equivalent 13. Patients unable to attend the 3-year follow-up

Design outcomes

Primary

MeasureTime frame
Measured at 6-month and 3-year follow-up: 1. Implant failure. 2. Complications (including re-treatments). 3. Change in radiographic bone level is measured using periapical intraoral radiographs taken with the parallel technique at baseline, 6 months and 3 years follow-up. Reference points for the linear measurements were the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. The mesial and distal sites were averaged for each implant. The radiographic measurements were relativized considering the length of the implant. The radiographs were examined by one masked examiner. 4. Change in pocket depth is measured at 4 sites of the implant (vestibular, mesial, distal and lingual) using a PCP-15 periodontal probe (Hu-Friedy) at baseline, 6 months and 3 years follow-up. 5. Change in recession depth is measured at 4 sites of the implant (vestibular, mesial, distal and lingual) using a PCP-15 periodontal probe (Hu-Friedy) at baseline, 6 months and 3 years follow-up. 6. Bleeding on probing.

Secondary

MeasureTime frame
1. Pain measured using VAS will be assessed immediately after the procedure, after 1 week, after 6 months, and after 3 years. 2. Satisfaction measured using VAS after 6 months and 3 years. 3. Oral health-related quality of life measured using the Oral Health Impacts Profile (OHIP-14) after 6 months and 3 years. 4. Variation in keratinized tissue (KT) is measured at mid-buccally using a PCP-15 periodontal probe at baseline, 6 months and 3 years follow-up. 5. Variation in clinical attachment level (CAL) is registered adding the values of probing depth and recession depth at baseline, 6 months and 3 years follow-up. 6. Subgingival bacterial samples will be taken immediately before debridement and at 1 month and 6 months after debridement.

Countries

Italy

Contacts

Public ContactMauro Merli
mauromerli@gmail.com+39-0541-52025

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026