Implant Healing Abutment and Chlorhexidine

Periimplantitis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142828
• Other study ID #: 1366/2016
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2017
• Last updated: November 26, 2017
• Start date: April 15, 2017
• Est. completion date: November 26, 2017

Study information

• Verified date: November 2017
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 26, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peri-Implantitis
• Periimplantitis

Intervention

Drug:
• Chlorhexidine
Healing abutment with Clorhexidine

Other:
• Placebo
Healing abutment without any antiseptic

Locations

Country	Name	City	State
Spain	Odontologic Universitary Clinic	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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