Periimplantitis
Conditions
Keywords
chlorhexidine, dental implant, in-situ drug delivery,
Brief summary
The work hyposesis is based on the application of a chlorhexidine gel against the non-application on the healing abutments in patients who have received a submerged titanium implant to check its effect on healing and prevention of bacterial plaque accumulation during a period of 1 month.
Detailed description
Once the implants are integrated, and given the consent, the patients will be operated to connect the healing abutments as they come from the manufacturer (Mozo Grau, Ticare®). Patients will follow the study protocol in 2 arms. The random distribution is made prior to assignment following the internet program https://www.random.org
Interventions
DRUGChlorhexidine
Healing abutment with Clorhexidine
OTHERPlacebo
Healing abutment without any antiseptic
Sponsors
Universidad de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blindness performed for patients and for statistical analysis
Intervention model description
After the first week, the healling abutment will be randomly distributed in a test group with application of chlorhexidine gel or a control group without the application of the chlorhexidine gel.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Good systemic health status (ASA I or II). * No current pain. * No use of painkillers or Anti-inflammatory drugs in the prior weeks. * Older than 18 years. * Oral hygiene index of ≤ 2 (Löe and Silness). * A minimum of 2 mm of adhered gum. * A minimum of 8 mm of vertical bone. * A minimum of 7 mm of vestibule-lingual bone. * Scheduled to receive a unitary implant. * Willing to participate in this controlled study.
Exclusion criteria
* Pregnant or nursing women. * Use of any type of medication that might affect the perception of pain. * An history of alcohol or drug abuse. * A requirement for guided regeneration or sinus lifting procedures. * Failure to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of inflammation | 1 month after second surgery | Degree of inflammation was measured using a 4-point Likert scaleInflammation 0 = non-inflamed gingiva with pale pink color. Inflammation 1 = erythematous gingiva without bleeding on manipulation. Inflammation 2 = gingiva with slight bleeding during manipulation during unscrewing or screwing of the abutment. Inflammation 3 = gingiva with heavy bleeding during manipulation during unscrewing or screwing of the abutment. |
Countries
Spain
Outcome results
None listed