Implant Healing Abutment and Chlorhexidine

NCT ID: NCT03142828

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2017-11-26

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

Conditions

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Periimplantitis

Keywords

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chlorhexidine, dental implant, in-situ drug delivery,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double blindness performed for patients and for statistical analysis

Study Groups

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Test (clorhexidine gel)

The healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants).

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

Healing abutment with Clorhexidine

Placebo

The healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Healing abutment without any antiseptic

Interventions

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Chlorhexidine

Healing abutment with Clorhexidine

Intervention Type DRUG

Placebo

Healing abutment without any antiseptic

Intervention Type OTHER

Other Intervention Names

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CHX

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Arturo Sánchez-Pérez

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arturo Sánchez-Pérez, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidad de Murcia

Locations

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Odontologic Universitary Clinic

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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1366/2016

Identifier Type: -

Identifier Source: org_study_id