CompletedNot Applicable

Radiographic Evaluation of a Star-shaped Incision Technique

China24 participantsStarted 2019-06-01

Plain-language 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.

Who can participate

Age range

22 Years – 58 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Papilla height

Timeframe: Between June 2019 and June 2021

Modified Plaque Index (mPI)

Timeframe: Between June 2019 and June 2021

Modified Sulcus Bleeding Index (mBI)

Timeframe: Between June 2019 and June 2021

Probing Depth (PD, mm)

Timeframe: Between June 2019 and June 2021

Gingival margin level (GML)

Timeframe: Between June 2019 and June 2021

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

Timeframe: Between June 2019 and June 2021

Trial details

NCT IDNCT05190614

SponsorWen Luo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-01

View on ClinicalTrials.gov More Clinical and Radiographic Effect trials

Plain-language summary

Who can participate

Age range

22 Years – 58 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Papilla height

Timeframe: Between June 2019 and June 2021

Modified Plaque Index (mPI)

Timeframe: Between June 2019 and June 2021

Modified Sulcus Bleeding Index (mBI)

Timeframe: Between June 2019 and June 2021

Probing Depth (PD, mm)

Timeframe: Between June 2019 and June 2021

Gingival margin level (GML)

Timeframe: Between June 2019 and June 2021

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

Timeframe: Between June 2019 and June 2021