Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique

Implant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706078
• Other study ID #: 2009033
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: January 2021
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Clinical and Radiographic Effect
• Implant
• Surgical Wound
• Thick-gingiva
• Thin Gingiva

Intervention

Diagnostic Test:
• The biotype of gingival
The biotype of gingival was also determined by periodontal probe.

Locations

Country	Name	City	State
China	West China Hospital of Stomatology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Wen Luo

Country where clinical trial is conducted

China, 

References & Publications (1)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	papilla height	Presence/absence of papilla height was assessed visually	Between June 2018 and June 2020.
Primary	Modified Plaque Index (mPI)	plaque accumulation around the marginal peri-implant tissue was assessed	Between June 2018 and June 2020.
Primary	Modified Sulcus Bleeding Index	the bleeding tendency of the marginal peri-implant tissue was evaluated	Between June 2018 and June 2020.
Primary	Probing Depth (PD, in millimeters)	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	Between June 2018 and June 2020.
Primary	Gingival margin level	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	Between June 2018 and June 2020.
Secondary	first bone-implant contact (fBIC) and implant shoulder (IS)	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.	Between June 2018 and June 2020.