Implant Healing Abutment and Chlorhexidine

Phase 4

Completed

• Conditions: Periimplantitis
• Interventions: Other: Placebo; Drug: Chlorhexidine

• Registration Number: NCT03142828
• Lead Sponsor: Universidad de Murcia

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

Study Timeline

• Study First Submitted: 2017-03-20
• Study Start: 2017-04-15
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-05
• Primary Completion: 2017-06-01
• Status Verified: 2017-11
• Study Completion: 2017-11-26
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants).
Test (clorhexidine gel)	Chlorhexidine	The healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Odontologic Universitary Clinic; 🇪🇸 Murcia, Spain