Clinical and Radiographic EffectNCT04706078

Clinical and Radiographic Evaluation of a Cross-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 cross-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Clinical and Radiographic Effect, Thick-gingiva, Implant
What is being tested?: The biotype of gingival
How many people: 55 participants
Where: 1 siteChina
Study dates: 1 Jun 2018to 1 Jun 2020
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: The study samples were comprised of patients who had been treated with one bone-level implant (Osstem, Korea) insertion in the first molar region. Fifty-five 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 2018 and June 2020.

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 the study had been treated with one bone-level implant insertion in the premolar or molar region.

Who cannot join

Active periodontal infections.
Heavy smoking habit (>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: Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique to Thick-gingiva and Thin-gingiva Patients Treated With Implant-supported Fixed Prosthesis

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

Read the 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.

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

What participants receive

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

The biotype of gingivalDiagnostic test
The biotype of gingival was also determined by periodontal probe.

Study groups in NCT04706078
Study group	Role	What they receive
thick-gingiva group		After insertion of the probe into the facial aspect of the sulcus, the peri-implant biotype can be categorized as thick-gingiva (outline if the probe cannot be seen through the gingival)
thin-gingiva group		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) Receives: Diagnostic Test: The biotype of gingival

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
Measured: Between June 2018 and June 2020.
Modified Plaque Index (mPI)
plaque accumulation around the marginal peri-implant tissue was assessed
Measured: Between June 2018 and June 2020.
Modified Sulcus Bleeding Index
the bleeding tendency of the marginal peri-implant tissue was evaluated
Measured: Between June 2018 and June 2020.
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
Measured: Between June 2018 and June 2020.
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
Measured: Between June 2018 and June 2020.

Secondary outcomes (1)

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.
Measured: Between June 2018 and June 2020.

Timeline

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

1 Jun 20181 Jun 2020

First posted12 Jan 2021
Study start1 Jun 2018
Primary completion1 Jun 2020
Study completion1 Jun 2020

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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04706078
Sponsor's protocol ID: 2009033
Status last verified: Jan 2021
First submitted: 5 Jan 2021
Last updated: 12 Jan 2021
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;74:984-5. [2] Bidra AS. Nonsurgical management of inflammatory periimplant disease caused by food impaction: a clinical report. J Prosthet Dent 2014;111:96-100. [3] Koori H, Morimoto K, Tsukiyama Y, Koyano K. Statistical analysis of the diachronic loss of interproximal contact between fixed implant prostheses and adjacent teeth. Int J Prosthodont 2010;23:535-40. [4] Gastaldo JF, Cury PR, Sendyk WR. Effect of the vertical and horizontal distances between adjacent implants and between a tooth and an implant on the incidence of interproximal papilla. J Periodontol 2004;75:1242-6. [5] Chow YC, Wang HL. Factors and techniques influencing peri-implant papillae. Implant Dent 2010;19:208-19. [6] Müller HP, Heinecke A, Schaller N, Eger T. Masticatory mucosa in subjects with different periodontal phenotypes. J Clin Periodontol 2000;27:621-6. [7] Yao JW, Wang HL. Assessment of Peri-implant Soft Tissue Adaptive Pressure and Time After Provisional Restorations. Int J Periodontics Restorative Dent 2019;39: 809-15. [8] Salama H, Salama M. The role of orthodontic extrusive remodeling in the enhancement of soft and hard tissue profiles prior to implant placement: a systematic approach to the management of extraction site defects. Int J Periodontics Restorative Dent1993;13,312-33. [9] Man Y, Wang Y, Qu Y, Wang P, Gong P. A palatal roll envelope technique for peri-implant mucosa reconstruction: a prospective case series study. Int J Oral Maxillofac Surg 2013;42:660-5. [10] Agarwal C, Deora S, Abraham D, Gaba R, Kumar BT,Kudva P. Vascularized interpositional periosteal connective tissue flap: A modern approach to augment soft tissue. J Indian Soc Periodontol 2015;19:72-7. [11] Man Y , Wu Q , Wang T , Gong P, Gong T , Qu Y. Split pedicle roll envelope technique around implants and pontics: a prospective case series study. Int J Oral Maxillofac Surg 2015;44:1295-301. [12] Urdaneta RA, Daher S, Lery J, Emanuel K, Chuang SK. Factors associated with crestal bone gain on single-tooth locking-taper implants: the effect of nonsteroidal anti-inflammatory drugs. Int J Oral Maxillofac Implants 2011;26, 1063-78. [13] 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:,428-33. [14] 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;23:146-56. [15] Mombelli A, Van Oosten MA, Schurch EJ, Lan NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol 1987;2:145-51. [16] Chang M, Wennström 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: 185-94. [17] Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res 2008;19:635-41. [18] 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;24:37-41. [19] Cooper LF, Ellner S, Moriarty J, Felton DA, Paquette D, Molina A, et al. Three-year evaluation of single-tooth implants restored 3 weeks after 1-stage surgery. Int J Oral Maxillofac Implants 2007;22:791-800. [20] Kan JY, Rungcharassaeng K, Liddelow G, Henry P, Goodacre CJ. Periimplant tissue response following immediate provisional restoration of scalloped implants in the esthetic zone: a one-year pilot prospective multicenter study. J Prosthet Dent 2007;97:109-18. [21] Al-Juboori MJ. Interdental Implant Papillae Grow up with Temporary Abutment displaced at Monthly Intervals. J Contemp Dent Pract 2015;16:422-6. [22] Finelle G, Papadimitriou D, Souza A, Katebi N,Gallucci G, Araújo M. Peri-implant soft tissue and marginal bone adaptation on implant with non-matching healing abutments: micro-CT analysis. Clin Oral Implants Res 2015;26:42-6. [23] Farronato D, Santoro G, Canullo L, Botticelli D, Maiorana C, Lang N. Establishment of the epithelial attachment and connective tissue adaptation to implants installed under the concept of
Luo W, Wang X, Chen Y, Hong Y, Qu Y, Man Y, Wu Y. Radiographic evaluation of a cross-shaped incision technique for thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. BMC Oral Health. 2021 Dec 18;21(1):655. doi: 10.1186/s12903-021-02019-8.
PubMed 34922521

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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04706078
Acronym / sponsor ID: 2009033
Conditions: Clinical and Radiographic Effect, Thick-gingiva, Implant, Thin Gingiva
Study type: Observational
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Wen LuoUniversity, hospital or other
Study start: 1 Jun 2018 (actual)
Primary completion: 1 Jun 2020 (actual)
Study completion: 1 Jun 2020 (actual)
First posted: 12 Jan 2021 (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.

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

Detailed description

Study design

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

Arm	Type	Receives
thick-gingiva group	–	–After insertion of the probe into the facial aspect of the sulcus, the peri-implant biotype can be categorized as thick-gingiva (outline if the probe cannot be seen through the gingival)
thin-gingiva group	–	Diagnostic Test: The biotype of gingivalAfter 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)

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: The study samples were comprised of patients who had been treated with one bone-level implant (Osstem, Korea) insertion in the first molar region. Fifty-five 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 2018 and June 2020.

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 the study had been treated with one bone-level implant insertion in the premolar or molar region.

Key exclusion criteria (2 listed)

Active periodontal infections.
Heavy smoking habit (>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 gingivalThe biotype of gingival was also determined by periodontal probe.	Diagnostic test	thin-gingiva group

Primary outcome

papilla height
Time frame: Between June 2018 and June 2020.
Presence/absence of papilla height was assessed visually
Modified Plaque Index (mPI)
Time frame: Between June 2018 and June 2020.
plaque accumulation around the marginal peri-implant tissue was assessed
Modified Sulcus Bleeding Index
Time frame: Between June 2018 and June 2020.
the bleeding tendency of the marginal peri-implant tissue was evaluated
Probing Depth (PD, in millimeters)
Time frame: 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
Time frame: 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

1 secondary outcome

first bone-implant contact (fBIC) and implant shoulder (IS)
Time frame: Between June 2018 and June 2020.

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 12 Jan 2021.
Background[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;74:984-5. [2] Bidra AS. Nonsurgical management of inflammatory periimplant disease caused by food impaction: a clinical report. J Prosthet Dent 2014;111:96-100. [3] Koori H, Morimoto K, Tsukiyama Y, Koyano K. Statistical analysis of the diachronic loss of interproximal contact between fixed implant prostheses and adjacent teeth. Int J Prosthodont 2010;23:535-40. [4] Gastaldo JF, Cury PR, Sendyk WR. Effect of the vertical and horizontal distances between adjacent implants and between a tooth and an implant on the incidence of interproximal papilla. J Periodontol 2004;75:1242-6. [5] Chow YC, Wang HL. Factors and techniques influencing peri-implant papillae. Implant Dent 2010;19:208-19. [6] Müller HP, Heinecke A, Schaller N, Eger T. Masticatory mucosa in subjects with different periodontal phenotypes. J Clin Periodontol 2000;27:621-6. [7] Yao JW, Wang HL. Assessment of Peri-implant Soft Tissue Adaptive Pressure and Time After Provisional Restorations. Int J Periodontics Restorative Dent 2019;39: 809-15. [8] Salama H, Salama M. The role of orthodontic extrusive remodeling in the enhancement of soft and hard tissue profiles prior to implant placement: a systematic approach to the management of extraction site defects. Int J Periodontics Restorative Dent1993;13,312-33. [9] Man Y, Wang Y, Qu Y, Wang P, Gong P. A palatal roll envelope technique for peri-implant mucosa reconstruction: a prospective case series study. Int J Oral Maxillofac Surg 2013;42:660-5. [10] Agarwal C, Deora S, Abraham D, Gaba R, Kumar BT,Kudva P. Vascularized interpositional periosteal connective tissue flap: A modern approach to augment soft tissue. J Indian Soc Periodontol 2015;19:72-7. [11] Man Y , Wu Q , Wang T , Gong P, Gong T , Qu Y. Split pedicle roll envelope technique around implants and pontics: a prospective case series study. Int J Oral Maxillofac Surg 2015;44:1295-301. [12] Urdaneta RA, Daher S, Lery J, Emanuel K, Chuang SK. Factors associated with crestal bone gain on single-tooth locking-taper implants: the effect of nonsteroidal anti-inflammatory drugs. Int J Oral Maxillofac Implants 2011;26, 1063-78. [13] 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:,428-33. [14] 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;23:146-56. [15] Mombelli A, Van Oosten MA, Schurch EJ, Lan NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol 1987;2:145-51. [16] Chang M, Wennström 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: 185-94. [17] Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res 2008;19:635-41. [18] 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;24:37-41. [19] Cooper LF, Ellner S, Moriarty J, Felton DA, Paquette D, Molina A, et al. Three-year evaluation of single-tooth implants restored 3 weeks after 1-stage surgery. Int J Oral Maxillofac Implants 2007;22:791-800. [20] Kan JY, Rungcharassaeng K, Liddelow G, Henry P, Goodacre CJ. Periimplant tissue response following immediate provisional restoration of scalloped implants in the esthetic zone: a one-year pilot prospective multicenter study. J Prosthet Dent 2007;97:109-18. [21] Al-Juboori MJ. Interdental Implant Papillae Grow up with Temporary Abutment displaced at Monthly Intervals. J Contemp Dent Pract 2015;16:422-6. [22] Finelle G, Papadimitriou D, Souza A, Katebi N,Gallucci G, Araújo M. Peri-implant soft tissue and marginal bone adaptation on implant with non-matching healing abutments: micro-CT analysis. Clin Oral Implants Res 2015;26:42-6. [23] Farronato D, Santoro G, Canullo L, Botticelli D, Maiorana C, Lang N. Establishment of the epithelial attachment and connective tissue adaptation to implants installed under the concept of
Derived from this study: PubMed 34922521Luo W, Wang X, Chen Y, Hong Y, Qu Y, Man Y, Wu Y. Radiographic evaluation of a cross-shaped incision technique for thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. BMC Oral Health. 2021 Dec 18;21(1):655. doi: 10.1186/s12903-021-02019-8.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 12 Jan 2021. 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 2018 and June 2020.). The study lists 5 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 NCT04706078, 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 12 Jan 2021.