Contour Augmentation by Means of Connective Tissue Grafting Versus Guided Bone Regeneration

NCT05143242 | Completed

• 1 other identifier: 23-186
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction. A traditional approach to treat alveolar process deficiency is guided bone regeneration (GBR), however post-operative complications such as swelling, bleeding and pain are common and the aesthetic outcome may not be optimal. An alternative to the traditional GBR approach could be soft tissue contour augmentation using a connective tissue graft (CTG) at the buccal aspect. Possible advantages over GBR include less morbidity at the implant site, a superior aesthetic outcome since there is no need for vertical releasing incisions and less costs since there are no biomaterials to be used. The primary study objective is to compare the GBR and CTG group in terms of 2 and 3 dimensional tissue alterations, focusing on the amount of tissue gain and volume stability over time. The secondary study objectives are morbidity, overall radiographic, clinical and aesthetic outcomes.

Conditions

Guided Bone Regeneration

Keywords

connective tissue graft; dental implant; guided bone regeneration; single tooth

Outcome Measures

Primary Outcomes (1)

• Buccal soft tissue profile

  The volumetric analysis software (Swissmeda/SMOP, Zürich, Switzerland) calculated a mean dimensional change (mm3) within the AOI (area of interest) for each patient at T5 (3 years). Given the variable size in AOI (mm2) among patients, the mean dimensional change per area was transformed to a mean linear change in buccal soft tissue profile (BSP) in mm.

  Year 1 and 3

Secondary Outcomes (9)

• Midfacial recession

  Month 6; Year 1 and 3

• Buccal bone thickness

  Year 1 and 3

• Buccal soft tissue thickness

  Year 1 and 3

• Pink Esthetic Score

  Year 1 and 3

• Mucosal Scarring Index

  Year 1 and 3

Study Arms (2)

Guided bone regeneration: Control

ACTIVE COMPARATOR

Deproteinized bovine derived xenograft (Geistlich Bio-Oss® 0.25 - 1 mm, Geistlich Pharma AG, Wolhusen, Switzerland)

Procedure: Hard tissue augmentation at the buccal aspect of single implants.

Connective tissue graft: Test

ACTIVE COMPARATOR

Connective tissue graft harvested from the palate

Procedure: Soft tissue augmentation at the buccal aspect of single implants.

Interventions

Hard tissue augmentation at the buccal aspect of single implants. PROCEDURE

One or two releasing incisions are made. The periosteum is released and multiple bone perforations are made in the buccal bone prior to the application of deproteinized bovine derived xenograft. A Creos® membrane (Nobel Biocare, Gothenburg, Sweden) is used to cover the occlusal part of the alveolar crest and the xenograft particles. Finally, multiple single monofilament sutures are used for primary tension-free wound closure.

Guided bone regeneration: Control

Soft tissue augmentation at the buccal aspect of single implants. PROCEDURE

A CTG is taken from the palate and transplanted to the buccal side between the alveolar bone and the buccal flap. The CTG is secured with single monofilament sutures.

Connective tissue graft: Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al.1972
• Presence of a single tooth gap in the anterior maxilla (15 - 25) with both neighbouring teeth present
• Failing tooth at least 3 months earlier removed
• Class I defect at the single tooth gap as clinically assessed (buccopalatal loss of tissue with a normal apicocoronal ridge height) (Seibert, 1983)
• Signed informed consent
• Buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone

You may not qualify if:

• Systemic diseases
• Smoking
• (History of) periodontal disease
• Untreated caries lesions
• Need for horizontal bone augmentation at the time of implant placement

Sponsors & Collaborators

• University Ghent: lead

Related Publications (28)

• Akcali A, Schneider D, Unlu F, Bicakci N, Kose T, Hammerle CH. Soft tissue augmentation of ridge defects in the maxillary anterior area using two different methods: a randomized controlled clinical trial. Clin Oral Implants Res. 2015 Jun;26(6):688-95. doi: 10.1111/clr.12368. Epub 2014 Apr 10.

  PMID: 24720375 BACKGROUND

• Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

  PMID: 15691354 BACKGROUND

• Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.

  PMID: 2099210 BACKGROUND

• Buser D, Chappuis V, Kuchler U, Bornstein MM, Wittneben JG, Buser R, Cavusoglu Y, Belser UC. Long-term stability of early implant placement with contour augmentation. J Dent Res. 2013 Dec;92(12 Suppl):176S-82S. doi: 10.1177/0022034513504949. Epub 2013 Oct 24.

  PMID: 24158332 BACKGROUND

• Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.

  PMID: 23347346 BACKGROUND

• Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. doi: 10.1177/0022034517737755. Epub 2017 Oct 26.

  PMID: 29073362 BACKGROUND

• Cosyn J, Eghbali A, De Bruyn H, Collys K, Cleymaet R, De Rouck T. Immediate single-tooth implants in the anterior maxilla: 3-year results of a case series on hard and soft tissue response and aesthetics. J Clin Periodontol. 2011 Aug;38(8):746-53. doi: 10.1111/j.1600-051X.2011.01748.x.

  PMID: 21752044 BACKGROUND

• Cosyn J, Eghbali A, De Bruyn H, Dierens M, De Rouck T. Single implant treatment in healing versus healed sites of the anterior maxilla: an aesthetic evaluation. Clin Implant Dent Relat Res. 2012 Aug;14(4):517-26. doi: 10.1111/j.1708-8208.2010.00300.x. Epub 2010 Jul 17.

  PMID: 20662859 BACKGROUND

• De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.

  PMID: 26373422 BACKGROUND

• De Bruyckere T, Eeckhout C, Eghbali A, Younes F, Vandekerckhove P, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to re-establish convexity at the buccal aspect of single implants: A one-year CBCT analysis. J Clin Periodontol. 2018 Nov;45(11):1375-1387. doi: 10.1111/jcpe.13006.

  PMID: 30133718 BACKGROUND

• De Bruyckere T, Cabeza RG, Eghbali A, Younes F, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis. Clin Implant Dent Relat Res. 2020 Aug;22(4):468-476. doi: 10.1111/cid.12934. Epub 2020 Jul 19.

  PMID: 32686234 BACKGROUND

• De Rouck T, Collys K, Cosyn J. Single-tooth replacement in the anterior maxilla by means of immediate implantation and provisionalization: a review. Int J Oral Maxillofac Implants. 2008 Sep-Oct;23(5):897-904.

  PMID: 19014160 BACKGROUND

• Eghbali A, De Bruyn H, Cosyn J, Kerckaert I, Van Hoof T. Ultrasonic Assessment of Mucosal Thickness around Implants: Validity, Reproducibility, and Stability of Connective Tissue Grafts at the Buccal Aspect. Clin Implant Dent Relat Res. 2016 Feb;18(1):51-61. doi: 10.1111/cid.12245. Epub 2014 Jul 17.

  PMID: 25040828 BACKGROUND

• Eghbali A, Seyssens L, De Bruyckere T, Younes F, Cleymaet R, Cosyn J. A 5-year prospective study on the clinical and aesthetic outcomes of alveolar ridge preservation and connective tissue graft at the buccal aspect of single implants. J Clin Periodontol. 2018 Dec;45(12):1475-1484. doi: 10.1111/jcpe.13018. Epub 2018 Nov 5.

  PMID: 30290007 BACKGROUND

• Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

  PMID: 16307569 BACKGROUND

• Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.

  PMID: 22211307 BACKGROUND

• Hanser T, Khoury F. Alveolar Ridge Contouring with Free Connective Tissue Graft at Implant Placement: A 5-Year Consecutive Clinical Study. Int J Periodontics Restorative Dent. 2016 Jul-Aug;36(4):465-73. doi: 10.11607/prd.2730.

  PMID: 27333003 BACKGROUND

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 BACKGROUND

• Schneider D, Ender A, Truninger T, Leutert C, Sahrmann P, Roos M, Schmidlin P. Comparison between clinical and digital soft tissue measurements. J Esthet Restor Dent. 2014 May-Jun;26(3):191-9. doi: 10.1111/jerd.12084. Epub 2013 Dec 17.

  PMID: 24341747 BACKGROUND

• Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available.

  PMID: 6578906 BACKGROUND

• Thoma DS, Buranawat B, Hammerle CH, Held U, Jung RE. Efficacy of soft tissue augmentation around dental implants and in partially edentulous areas: a systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S77-91. doi: 10.1111/jcpe.12220.

  PMID: 24641003 BACKGROUND

• Thoma DS, Naenni N, Benic GI, Hammerle CH, Jung RE. Soft tissue volume augmentation at dental implant sites using a volume stable three-dimensional collagen matrix - histological outcomes of a preclinical study. J Clin Periodontol. 2017 Feb;44(2):185-194. doi: 10.1111/jcpe.12635. Epub 2017 Jan 3.

  PMID: 27716970 BACKGROUND

• Thoma DS, Bienz SP, Figuero E, Jung RE, Sanz-Martin I. Efficacy of lateral bone augmentation performed simultaneously with dental implant placement: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:257-276. doi: 10.1111/jcpe.13050.

  PMID: 30675733 BACKGROUND

• Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31.

  PMID: 27978602 BACKGROUND

• Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.

  PMID: 19929956 BACKGROUND

• Wessels R, De Roose S, De Bruyckere T, Eghbali A, Jacquet W, De Rouck T, Cosyn J. The Mucosal Scarring Index: reliability of a new composite index for assessing scarring following oral surgery. Clin Oral Investig. 2019 Mar;23(3):1209-1215. doi: 10.1007/s00784-018-2535-6. Epub 2018 Jul 3.

  PMID: 29971512 BACKGROUND

• Wiesner G, Esposito M, Worthington H, Schlee M. Connective tissue grafts for thickening peri-implant tissues at implant placement. One-year results from an explanatory split-mouth randomised controlled clinical trial. Eur J Oral Implantol. 2010 Spring;3(1):27-35.

  PMID: 20467596 BACKGROUND

• Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11.

  PMID: 28107560 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned to the control group (GBR) or test group (CTG). Simple randomization was performed using sealed envelopes with an equal number of envelopes for every treatment group. Group allocation was revealed just prior to surgery by the surgeon. The measuring clinician will not be involved in the treatment of any of the patients and will be blinded to allow unbiased registrations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: December 3, 2021
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share