Implant Healing Abutment and Chlorhexidine

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of the Application of Chlorhexidine in the Pillars of Implant Healing to Prevent Plate Accumulation. Controlled Random Blind Clinical Study.

Conditions
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Periimplantitis

Intervention / Treatment
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* Drug: Chlorhexidine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test (clorhexidine gel)<br>The healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants). | Drug: Chlorhexidine<br>* Healing abutment with Clorhexidine<br>* Other names: CHX;|
| Placebo Comparator: Placebo<br>The healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants). | Other: Placebo<br>* Healing abutment without any antiseptic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of inflammation | 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. | 1 month after second surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlorhexidine, dental implant, in-situ drug delivery,