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NCT Number: NCT05190614

Radiographic Evaluation of a Star-shaped Incision Technique

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.

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Key information

Conditions

Clinical and Radiographic Effect Implant Thick-gingiva Thin-gingiva

Age range

22 year–58 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital of Stomatology

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good general health, no chronic systemic diseases.
  • All subjects included in this study needed to have one missing premolar or molar teeth with adjacent natural teeth.
  • 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

  • Active periodontal infections.
  • Heavy smoking (> 10 cigarettes per day).

Treatment and study plan

The biotype of gingiva

Diagnostic Test

The biotype of gingival was determined by periodontal probe.

Primary outcomes

  1. Papilla height

    Time frame: Between June 2019 and June 2021

    Presence/absence of papilla height was assessed visually according to the papilla index proposed by Jemt

  2. Modified Plaque Index (mPI)

    Time frame: Between June 2019 and June 2021

    plaque accumulation around the marginal peri-implant tissue was assessed by the criteria of mPI

  3. Modified Sulcus Bleeding Index (mBI)

    Time frame: Between June 2019 and June 2021

    the bleeding tendency of the marginal peri-implant tissue was evaluated using mBI

  4. Probing Depth (PD, mm)

    Time frame: Between June 2019 and June 2021

    PD was assessed at the mid-buccal, mid-oral, mesial and distal aspects of the buccal surfaces of each implant with a standard periodontal probe, and final value was determined by the average of four aspects.

  5. Gingival margin level (GML)

    Time frame: Between June 2019 and June 2021

    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 (PMD)

  6. The landmarks of first bone-implant contact (fBIC) and implant shoulder (IS)

    Time frame: Between June 2019 and June 2021

    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. The crestal bone level at the time of impression taking was regarded as baseline. The known implant length was used for the calibration of dimensional distortion in the radiograph (the length of implant was 10 mm).

Sponsors and collaborators

Lead sponsor

Wen Luo

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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