search
Back to results

Implant Healing Abutment and Chlorhexidine (CHX-HA)

Primary Purpose

Periimplantitis

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Chlorhexidine
Placebo
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periimplantitis focused on measuring chlorhexidine, dental implant, in-situ drug delivery,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Odontologic Universitary Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test (clorhexidine gel)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2017
Last Updated
November 26, 2017
Sponsor
Universidad de Murcia
search

1. Study Identification

Unique Protocol Identification Number
NCT03142828
Brief Title
Implant Healing Abutment and Chlorhexidine
Acronym
CHX-HA
Official Title
Effect of the Application of Chlorhexidine in the Pillars of Implant Healing to Prevent Plate Accumulation. Controlled Random Blind Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
November 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periimplantitis
Keywords
chlorhexidine, dental implant, in-situ drug delivery,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Double blindness performed for patients and for statistical analysis
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test (clorhexidine gel)
Arm Type
Active Comparator
Arm Description
The healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants).
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
CHX
Intervention Description
Healing abutment with Clorhexidine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Healing abutment without any antiseptic
Primary Outcome Measure Information:
Title
Degree of inflammation
Description
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.
Time Frame
1 month after second surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Sánchez-Pérez, Professor
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odontologic Universitary Clinic
City
Murcia
ZIP/Postal Code
30008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Non-personal data
IPD Sharing Time Frame
After the publication of the results
IPD Sharing Access Criteria
Any interested researcher

Learn more about this trial

Implant Healing Abutment and Chlorhexidine

We'll reach out to this number within 24 hrs