Implant Healing Abutment and Chlorhexidine (CHX-HA)

Universidad de Murcia

Status and phase: Completed; Phase 4

Conditions: Periimplantitis

Treatments: Other: Placebo; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03142828

1366/2016

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Test (clorhexidine gel)

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo