Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique

Completed

• Conditions: Thin Gingiva; Implant; Clinical and Radiographic Effect; Thick-gingiva
• Interventions: Diagnostic Test: The biotype of gingival

• Registration Number: NCT04706078
• Lead Sponsor: Wen Luo

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
thin-gingiva group	The biotype of gingival	After insertion of the probe into the facial aspect of the sulcus, the peri-implant biotype can be categorized as thin-gingiva (outline of the probe can be seen through the gingival)

Primary Outcome Measures

Name	Time	Method
Modified Plaque Index (mPI)	Between June 2018 and June 2020.	plaque accumulation around the marginal peri-implant tissue was assessed
Probing Depth (PD, in millimeters)	Between June 2018 and June 2020.	PD was assessed at the mid-buccal, mid-oral, mesial and distal aspects of each implant with a standard periodontal probe, and final value was determined by the average of four aspects
Gingival margin level	Between June 2018 and June 2020.	Gingival margin level was assessed by calculating the vertical distance between the most apical point of gingival margin at the buccal aspect of the crown and line connecting the peak of the adjacent mesial and distal natural teeth
papilla height	Between June 2018 and June 2020.	Presence/absence of papilla height was assessed visually
Modified Sulcus Bleeding Index	Between June 2018 and June 2020.	the bleeding tendency of the marginal peri-implant tissue was evaluated

Secondary Outcome Measures

Name	Time	Method
first bone-implant contact (fBIC) and implant shoulder (IS)	Between June 2018 and June 2020.	the landmarks of first bone-implant contact (fBIC) and implant shoulder (IS) were used for measurements. fBIC-IS was defined as the vertical distance the first bone-implant contact to implant shoulder, and the distance was assessed at the mesial and distal aspect of implant, respectively. When the marginal crestal bone was located coronal to the IS, a positive (+) value was given, where a negative (-) value when located apically to the IS, the value was deemed as zero when IS and fBIC coincided.

Trial Locations

Locations (1)

West China Hospital of Stomatology; 🇨🇳 Chengdu, Sichuan, China