Clinical trial NCT04706078: Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique
Official title: Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique to Thick-gingiva and Thin-gingiva Patients Treated With Implant-supported Fixed Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical and Radiographic Effect
Thick-gingiva
Implant
Thin Gingiva
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study samples were comprised of patients who had been treated with one bone-level implant (Osstem, Korea) insertion in the first molar region. Fifty-five subjects were selected from the patients who came to the Department of Oral Implantology, West China Hospital of Stomatology, Sichuan University in China between June 2018 and June 2020.

Brief summary: To evaluate a cross-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis.

Detailed description: Objective: To evaluate a cross-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. Methods and Materials: 55 patients received cross-shaped incision were assigned into thick-gingiva group (29 cases) and thin-gingiva group (26 cases). Follow-up examination was carried out 3 and 12 months after final restoration. Clinical and radiographic evaluation including gingival papilla height, modified plaque index, modified sulcus bleeding index, periodontal depth, and crestal marginal bone level were utilized.

Eligibility criteria: Inclusion Criteria:

1. Good general health, no chronic systemic diseases.
2. All subjects included in this study needed to have one missing premolar or molar teeth with adjacent natural teeth.
3. All subjects included in the study had been treated with one bone-level implant insertion in the premolar or molar region.

Exclusion Criteria:

1. Active periodontal infections.
2. Heavy smoking habit (\>10 cigarettes per day).

Primary outcomes:
measure: papilla height
timeFrame: Between June 2018 and June 2020.
measure: Modified Plaque Index (mPI)
timeFrame: Between June 2018 and June 2020.
measure: Modified Sulcus Bleeding Index
timeFrame: Between June 2018 and June 2020.
measure: Probing Depth (PD, in millimeters)
timeFrame: Between June 2018 and June 2020.
measure: Gingival margin level
timeFrame: Between June 2018 and June 2020.
Secondary outcomes:
measure: first bone-implant contact (fBIC) and implant shoulder (IS)
timeFrame: Between June 2018 and June 2020.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology
state: Sichuan
Study officials:
References:
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citation: Luo W, Wang X, Chen Y, Hong Y, Qu Y, Man Y, Wu Y. Radiographic evaluation of a cross-shaped incision technique for thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. BMC Oral Health. 2021 Dec 18;21(1):655. doi: 10.1186/s12903-021-02019-8.