CHX-HA: Implant Healing Abutment and Chlorhexidine

Sponsor

Universidad de Murcia (Other)

Overall Status

Completed

CT.gov ID

NCT03142828

Collaborator

(none)

100

Enrollment

Location

Arms

7.4

Actual Duration (Months)

13.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periimplantitis	Drug: Chlorhexidine Other: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Outcomes Assessor)

Masking Description:

Double blindness performed for patients and for statistical analysis

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2017

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Nov 26, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odontologic Universitary Clinic	Murcia		Spain	30008

Sponsors and Collaborators

Universidad de Murcia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arturo Sánchez-Pérez, Associate professor, Universidad de Murcia

ClinicalTrials.gov Identifier:

NCT03142828

Other Study ID Numbers:

1366/2016

First Posted:

May 5, 2017

Last Update Posted:

Nov 28, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Arturo Sánchez-Pérez, Associate professor, Universidad de Murcia

chlorhexidine, dental implant, in-situ drug delivery,

Additional relevant MeSH terms:

Peri-Implantitis

Chlorhexidine

Study Results

No Results Posted as of Nov 28, 2017