Clinical and Radiographic EffectNCT05190614

Radiographic Evaluation of a Star-shaped Incision Technique

An observational study of Clinical and Radiographic Effect and Thick-gingiva, run by Wen Luo at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 22 to 58 yearsHealthy volunteers can take part
Conditions the study is for: Clinical and Radiographic Effect, Thick-gingiva, Thin-gingiva
What is being tested?: The biotype of gingiva
How many people: 24 participants
Where: 1 siteChina
Study dates: 1 Jun 2019to 1 Jun 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 58 years
All sexes
Healthy volunteers accepted
Adult

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.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital of Stomatology
Chengdu, Sichuan, 610041

Other trials in China

About this study

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

Read the 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.

Conditions: Clinical and Radiographic Effect, Thick-gingiva, Thin-gingiva, Implant
Being tested: The biotype of gingiva

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The biotype of gingivaDiagnostic test
The biotype of gingival was determined by periodontal probe.

Study groups in NCT05190614
Study group	Role	What they receive
thick-gingiva group		After the insertion of the probe into the facial aspect of the sulcus through the gingival margin, the simple visual method is based on the transparency of the periodontal probe through the gingival margin while probing the buccal sulcus at the midfacial aspect of the tooth. When the outline of the underlying periodontal probe can't be seen through the gingival, the gingival phenotype is considered thick.
thin-gingiva group		After the insertion of the probe into the facial aspect of the sulcus through the gingival margin, the simple visual method is based on the transparency of the periodontal probe through the gingival margin while probing the buccal sulcus at the midfacial aspect of the tooth. When the outline of the underlying periodontal probe can be seen through the gingival, the gingival phenotype is considered thin. Receives: Diagnostic Test: The biotype of gingiva

What is being measured

The primary outcome is the main question the study is designed to answer.

Papilla height
Presence/absence of papilla height was assessed visually according to the papilla index proposed by Jemt
Measured: Between June 2019 and June 2021
Modified Plaque Index (mPI)
plaque accumulation around the marginal peri-implant tissue was assessed by the criteria of mPI
Measured: Between June 2019 and June 2021
Modified Sulcus Bleeding Index (mBI)
the bleeding tendency of the marginal peri-implant tissue was evaluated using mBI
Measured: Between June 2019 and June 2021
Probing Depth (PD, mm)
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.
Measured: Between June 2019 and June 2021
Gingival margin level (GML)
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)
Measured: Between June 2019 and June 2021
The landmarks of first bone-implant contact (fBIC) and implant shoulder (IS)
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).
Measured: Between June 2019 and June 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20191 Jun 2021

First posted13 Jan 2022
Study start1 Jun 2019
Primary completion1 Jun 2021
Study completion1 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Clinical and Radiographic EffectStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05190614
Sponsor's protocol ID: 2019021
Status last verified: Dec 2021
First submitted: 14 Dec 2021
Last updated: 13 Jan 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

1. Du H, Gao M, Qi C, Liu S, Lin Y. Drug-induced gingival hyperplasia and scaffolds: they may be valuable for horizontal food impaction. Med Hypotheses 2010;74(6): 984-5. 2. Bidra AS. Nonsurgical management of inflammatory periimplant disease caused by food impaction: a clinical report. J Prosthet Dent 2014;111(2): 96-100. 3. Berglundh T, Lindhe J, Ericsson I, Mainello CP, Lijenberg B. The soft tissue barrier at implants and teeth. Clin Oral Implants Res 1991; 2: 81-90. 4. Berglundh T, Lindhe J, Jonsson K, Ericsson I. The topography of the vascular systems in the periodontal and peri-implant tissues in the dog. J Clin Periodontol 1994; 21: 189-93. 5. Chow YC, Wang HL. Factors and techniques influencing peri-implant papillae. Implant Dent 2010; 19(3): 208-19. 6. Sanavi F, Weisgold AS, Rose LF. Biologic width and its relation to periodontal biotypes. J Esthet Dent 1998; 10(3): 157-63. 7. De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol 2009; 36(5): 428-33. 8. Olsson M, Lindhe J. Periodontal characteristics in individuals with varying form of the upper central incisors. J Clin Periodontol 1991; 18(1): 78-82. 9. Pontoriero R, Carnevale G. Surgical crown lengthening: a 12-month clinical wound healing study. J Periodontol 2001;72(7): 841-8. 10. Ronay V, Sahrmann P, Bindl A, Attin T, Schmidlin PR. Current status and perspectives of mucogingival soft tissue measurement methods. J Esthet Restor Dent 2011; 23(3):146-56. 11. Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol 1987; 2(4):145-51. 12. Chang M, Wenstrom JL, Odman P, Andersson B. Implant supported single-tooth replacements compared to contralateral natural teeth. Crown and soft tissue dimensions. Clin Oral Implants Res 1999; 10(3): 185-94. 13. Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res 2008;19(7): 635-41. 14. Kajiwara N, Masaki C, Mukaibo T, Kondo Y, Nakamoto T, Hosokawa R. Soft tissue biological response to zirconia and metal implant abutments compared with natural tooth: microcirculation monitoring as a novel bioindicator. Implant Dent 2015; 24(1): 37-41. 15. Muller HP, Heinecke A, Schaller N, Eger T. Masticatory mucosa in subjects with different periodontal phenotypes. J Clin Periodontol 2000; 27(9):621-6. 16. Pradeep AR, Karthikeyan BV. Peri-implant papilla reconstruction: realities and limitations. J Periodontol, 2006. 77(3): p. 534-44. 17. Kan JY, Rungcharassaeng K, Umezu K, Kois JC. Dimensions of peri-implant mucosa: an evaluation of maxillary anterior single implants in humans. J Periodontol 2003;74(4):557-62. 18. Finelle G, Papadimitriou DE, Souza AB, Katebi N, Gallucci GO, Araujo MG. Peri-implant soft tissue and marginal bone adaptation on implant with non-matching healing abutments: micro-CT analysis. Clin Oral Implants Res, 2015; 26(4): e42-6. 19. Farronato D, Santoro G, Canullo L, Botticelli D, Maiorana C, Lang NP. Establishment of the epithelial attachment and connective tissue adaptation to implants installed under the concept of
Luo W, Kuang H, Sun H, Huang Y, Wang J, Zheng K, Li Z, Qu Y, Man Y, Wu Y. Star-shaped incision technique for gingiva patients treated with implant-supported fixed prosthesis. Medicine (Baltimore). 2023 Jul 7;102(27):e34324. doi: 10.1097/MD.0000000000034324.
PubMed 37417601

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05190614
Acronym / sponsor ID: 2019021
Conditions: Clinical and Radiographic Effect, Thick-gingiva, Thin-gingiva, Implant
Study type: Observational
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Wen LuoUniversity, hospital or other
Study start: 1 Jun 2019 (actual)
Primary completion: 1 Jun 2021 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 13 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
thick-gingiva group	–	–After the insertion of the probe into the facial aspect of the sulcus through the gingival margin, the simple visual method is based on the transparency of the periodontal probe through the gingival margin while probing the buccal sulcus at the midfacial aspect of the tooth. When the outline of the underlying periodontal probe can't be seen through the gingival, the gingival phenotype is considered thick.
thin-gingiva group	–	Diagnostic Test: The biotype of gingivaAfter the insertion of the probe into the facial aspect of the sulcus through the gingival margin, the simple visual method is based on the transparency of the periodontal probe through the gingival margin while probing the buccal sulcus at the midfacial aspect of the tooth. When the outline of the underlying periodontal probe can be seen through the gingival, the gingival phenotype is considered thin.

Who may qualify

Ages: 22 to 58 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The biotype of gingivaThe biotype of gingival was determined by periodontal probe.	Diagnostic test	thin-gingiva group

Primary outcome

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
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
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
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.
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)
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
Background1. Du H, Gao M, Qi C, Liu S, Lin Y. Drug-induced gingival hyperplasia and scaffolds: they may be valuable for horizontal food impaction. Med Hypotheses 2010;74(6): 984-5. 2. Bidra AS. Nonsurgical management of inflammatory periimplant disease caused by food impaction: a clinical report. J Prosthet Dent 2014;111(2): 96-100. 3. Berglundh T, Lindhe J, Ericsson I, Mainello CP, Lijenberg B. The soft tissue barrier at implants and teeth. Clin Oral Implants Res 1991; 2: 81-90. 4. Berglundh T, Lindhe J, Jonsson K, Ericsson I. The topography of the vascular systems in the periodontal and peri-implant tissues in the dog. J Clin Periodontol 1994; 21: 189-93. 5. Chow YC, Wang HL. Factors and techniques influencing peri-implant papillae. Implant Dent 2010; 19(3): 208-19. 6. Sanavi F, Weisgold AS, Rose LF. Biologic width and its relation to periodontal biotypes. J Esthet Dent 1998; 10(3): 157-63. 7. De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol 2009; 36(5): 428-33. 8. Olsson M, Lindhe J. Periodontal characteristics in individuals with varying form of the upper central incisors. J Clin Periodontol 1991; 18(1): 78-82. 9. Pontoriero R, Carnevale G. Surgical crown lengthening: a 12-month clinical wound healing study. J Periodontol 2001;72(7): 841-8. 10. Ronay V, Sahrmann P, Bindl A, Attin T, Schmidlin PR. Current status and perspectives of mucogingival soft tissue measurement methods. J Esthet Restor Dent 2011; 23(3):146-56. 11. Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol 1987; 2(4):145-51. 12. Chang M, Wenstrom JL, Odman P, Andersson B. Implant supported single-tooth replacements compared to contralateral natural teeth. Crown and soft tissue dimensions. Clin Oral Implants Res 1999; 10(3): 185-94. 13. Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res 2008;19(7): 635-41. 14. Kajiwara N, Masaki C, Mukaibo T, Kondo Y, Nakamoto T, Hosokawa R. Soft tissue biological response to zirconia and metal implant abutments compared with natural tooth: microcirculation monitoring as a novel bioindicator. Implant Dent 2015; 24(1): 37-41. 15. Muller HP, Heinecke A, Schaller N, Eger T. Masticatory mucosa in subjects with different periodontal phenotypes. J Clin Periodontol 2000; 27(9):621-6. 16. Pradeep AR, Karthikeyan BV. Peri-implant papilla reconstruction: realities and limitations. J Periodontol, 2006. 77(3): p. 534-44. 17. Kan JY, Rungcharassaeng K, Umezu K, Kois JC. Dimensions of peri-implant mucosa: an evaluation of maxillary anterior single implants in humans. J Periodontol 2003;74(4):557-62. 18. Finelle G, Papadimitriou DE, Souza AB, Katebi N, Gallucci GO, Araujo MG. Peri-implant soft tissue and marginal bone adaptation on implant with non-matching healing abutments: micro-CT analysis. Clin Oral Implants Res, 2015; 26(4): e42-6. 19. Farronato D, Santoro G, Canullo L, Botticelli D, Maiorana C, Lang NP. Establishment of the epithelial attachment and connective tissue adaptation to implants installed under the concept of
Derived from this study: PubMed 37417601Luo W, Kuang H, Sun H, Huang Y, Wang J, Zheng K, Li Z, Qu Y, Man Y, Wu Y. Star-shaped incision technique for gingiva patients treated with implant-supported fixed prosthesis. Medicine (Baltimore). 2023 Jul 7;102(27):e34324. doi: 10.1097/MD.0000000000034324.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaohui Zheng, MD principal investigator

West China Hospital of Stomatology, Sichuan University, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Clinical and Radiographic Effect and Thick-gingiva, run by Wen Luo at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Papilla height (time frame: Between June 2019 and June 2021). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05190614, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.