Implant Healing Abutment and Chlorhexidine (CHX-HA)

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

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.

Study Overview

• Status: Completed
• Conditions: Periimplantitis
• Intervention / Treatment: Drug: Chlorhexidine; Other: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30008
    • Odontologic Universitary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Investigators: Principal Investigator: Arturo Sánchez-Pérez, Professor, Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2017
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): November 26, 2017

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 26, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: chlorhexidine, dental implant, in-situ drug delivery,
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 1366/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Non-personal data
• IPD Sharing Time Frame: After the publication of the results
• IPD Sharing Access Criteria: Any interested researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No