Clinical and Radiographic Evaluation of a Cross-shaped Incision Technique

NCT04706078 | Completed

• 1 other identifier: 2009033
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Clinical and Radiographic Effect; Thick-gingiva; Implant; Thin Gingiva

Outcome Measures

Primary Outcomes (5)

• papilla height

  Presence/absence of papilla height was assessed visually

  Between June 2018 and June 2020.

• Modified Plaque Index (mPI)

  plaque accumulation around the marginal peri-implant tissue was assessed

  Between June 2018 and June 2020.

• Modified Sulcus Bleeding Index

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

  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

  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

  Between June 2018 and June 2020.

Secondary Outcomes (1)

• first bone-implant contact (fBIC) and implant shoulder (IS)

  Between June 2018 and June 2020.

Study Arms (2)

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)

Diagnostic Test: The biotype of gingival

Interventions

The biotype of gingival DIAGNOSTIC_TEST

The biotype of gingival was also determined by periodontal probe.

thin-gingiva group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wen Luo: lead

Study Sites (1)

West China Hospital of Stomatology

Chengdu, Sichuan, 610041, China

Location

Related Publications (2)

• [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

  BACKGROUND

• 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.

  PMID: 34922521 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 12, 2021
• Study Start: June 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)