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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03142828
Other study ID # 1366/2016
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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