Radiographic Evaluation of a Star-shaped Incision Technique

Radiographic Evaluation of a Star-shaped Incision Technique for Thick-gingiva and Thin-gingiva Patients Treated With Implant-supported Fixed Prosthesis: a Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Implant; Thin-gingiva; Clinical and Radiographic Effect; Thick-gingiva
• Intervention / Treatment: Diagnostic test: The biotype of gingiva

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Stomatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 58 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 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

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: The biotype of gingiva; The biotype of gingival was determined by periodontal probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Papilla height	Presence/absence of papilla height was assessed visually according to the papilla index proposed by Jemt	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	Between June 2019 and June 2021
Modified Sulcus Bleeding Index (mBI)	the bleeding tendency of the marginal peri-implant tissue was evaluated using mBI	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.	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)	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).	Between June 2019 and June 2021

Collaborators and Investigators

• Sponsor: Wen Luo
• Investigators: Principal Investigator: Xiaohui Zheng, MD, West China Hospital of Stomatology, Sichuan University, China

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (ACTUAL): January 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No