Clinical trial NCT05190614: Radiographic Evaluation of a Star-shaped Incision Technique
Official title: Radiographic Evaluation of a Star-shaped Incision Technique for Thick-gingiva and Thin-gingiva Patients Treated With Implant-supported Fixed Prosthesis: a Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical and Radiographic Effect
Thick-gingiva
Thin-gingiva
Implant
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Maximum age (years): 58
Standard ages: 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 premolar or molar region. Twenty-four 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 2019 and June 2021.

Brief summary: To evaluate a star-shaped incision technique to thick-gingiva and thingingiva patients treated with implant-supported fixed prosthesis. The star-shaped incision would be an effective and simple method to reconstruct gingival papillae and avoid the gingival recession in thick-gingiva patients treated with implant-supported fixed prosthesis, and it is worthy of clinical extend.

Detailed description: Objective: To evaluate a star-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. Methods and Materials: 24 patients received cross-shaped incision were assigned into thick-gingiva group (16 cases) and thin-gingiva group (8 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 this study had been treated with one bone-level implant insertion in the premolar or molar region. The patients had insufficient gingival papilla height (referred to contralateral natural tooth which also had insufficient gingival papilla height) and at least 2 mm of keratinized tissue width around the implant.

Exclusion criteria

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

Primary outcomes:
measure: Papilla height
timeFrame: Between June 2019 and June 2021
measure: Modified Plaque Index (mPI)
timeFrame: Between June 2019 and June 2021
measure: Modified Sulcus Bleeding Index (mBI)
timeFrame: Between June 2019 and June 2021
measure: Probing Depth (PD, mm)
timeFrame: Between June 2019 and June 2021
measure: Gingival margin level (GML)
timeFrame: Between June 2019 and June 2021
measure: The landmarks of first bone-implant contact (fBIC) and implant shoulder (IS)
timeFrame: Between June 2019 and June 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology
state: Sichuan
Study officials:
affiliation: West China Hospital of Stomatology, Sichuan University, China
name: Xiaohui Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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