Effects of the SIS Membrane on GBR and Early Loading of Maxillary Anterior Dental Implants

NCT06574815 | Completed DMC

• 2 other identifiers: CMUSH-IRB-KJ-PJ-2023-24CSA-SIS2022-17
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial (RCT) is to determine whether early implant loading that shortens the healing period to 6 weeks can be safely and effectively applied to implants with good initial stability in the maxillary anterior region, which undergoes simultaneous guided bone regeneration (GBR), via clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring, and to determine the clinical effect of the small intestine submucosa (SIS) biological barrier membrane in such cases involving early loading. This study is expected to provide preliminary guidance on the timing of loading for a single maxillary anterior implant with insufficient bone volume and provide a theoretical basis for the selection of a biological barrier membrane for GBR in such patients.

Conditions

Dental Implantation; Guided Bone Regeneration

Keywords

Dental implantation; Guided bone regeneration; Early loading; Small intestine submucosa membranes; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Soft tissue contour assessment

  Intraoral scanning was used to collect the soft tissue contour at the implant site, the contour of the implant-supported crown and adjacent natural teeth. The preoperative, immediate postoperative, and 1-year follow-up intraoral scanning data in stereolithography (STL) formats were imported into Exocad 3.0 software. The best-fit images of the median sagittal section at the implant site were extracted, and the horizontal contour changes (HCCs) were measured at 1 mm and 3 mm below the crown-gingiva margin. The preoperative contour was used as the baseline to detect the immediate postoperative horizontal contour increase (HCI), and the immediate postoperative contour was used as another baseline to detect the 1-year follow-up horizontal contour decrease (HCD).

  At the 1-year follow-up

• Marginal bone level assessment

  X-ray images immediately postoperative (baseline) and at the 1-year follow-up were taken, and the distances from the most coronal bone-to-implant or bone-to-superstructure contact point to the reference point (neck margin of the implant) were measured at the mesial and distal sides of the implant; then, the data were averaged. Negative values were recorded when the contact point was at the root side of the reference point, and positive values were recorded when the contact point was at the crown side of the reference point. The data were calibrated with the known length of the implant to correct for distortion. The MBL changes were obtained by subtracting the baseline data from the 1-year follow-up data.

  At the 1-year follow-up

Study Arms (3)

SIS-EL

EXPERIMENTAL

Guided bone regeneration (GBR) with an SIS membrane and early implant loading

Procedure: Early implant loading; Procedure: GBR using an SIS membrane

Gide-EL

ACTIVE COMPARATOR

Guided bone regeneration (GBR) with a Bio-Gide membrane and early implant loading

Procedure: Early implant loading; Procedure: GBR using an Bio-Gide membrane

Gide-DL

SHAM COMPARATOR

Guided bone regeneration (GBR) with a Bio-Gide membrane and delayed implant loading

Procedure: Delayed implant loading; Procedure: GBR using an Bio-Gide membrane

Interventions

Early implant loading PROCEDURE

Patients underwent definitive restoration at 6 weeks after implant surgery (early loading).

Gide-EL; SIS-EL

Delayed implant loading PROCEDURE

Patients underwent definitive restoration at 6 months after implant surgery (delayed loading).

Gide-DL

GBR using an SIS membrane PROCEDURE

An small intestine submucosa (SIS) membrane was used in the guided bone regeneration (GBR) surgery.

SIS-EL

GBR using an Bio-Gide membrane PROCEDURE

An Bio-Gide membrane was used in the guided bone regeneration (GBR) surgery.

Gide-DL; Gide-EL

Eligibility Criteria

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

You may qualify if:

• patients with single maxillary anterior tooth loss (sites: 12, 11, 21, 22);
• age ≥18 years;
• sex not limited;
• no history of systemic diseases such as heart disease, hypertension, or diabetes;
• no periodontal disease or already received periodontal systemic treatment;
• cone-beam computed tomography (CBCT) revealed that the thickness of the alveolar ridge in the tooth loss area was greater than 3 mm but less than 5 mm;
• using hydrophilic-modified sandblasted and acid-etched (SLActive) bone level tapered (BLT) dental implant systems.

You may not qualify if:

• patients receiving radiotherapy and chemotherapy;
• patients with a history of hepatitis, tuberculosis, or other infectious diseases;
• patients with very poor oral hygiene;
• patients who were heavy smokers;
• pregnant women.

Sponsors & Collaborators

• Beijing Stomatological Hospital, Capital Medical University: lead

Study Sites (1)

Beijing Stomatological Hospital, Capital Medical University

Beijing, China

Location

Related Publications (14)

• Liu R, Yang Z, Tan J, Chen L, Liu H, Yang J. Immediate implant placement for a single anterior maxillary tooth with a facial bone wall defect: A prospective clinical study with a one-year follow-up period. Clin Implant Dent Relat Res. 2019 Dec;21(6):1164-1174. doi: 10.1111/cid.12854. Epub 2019 Nov 11.

  PMID: 31709704 BACKGROUND

• Benic GI, Ge Y, Gallucci GO, Jung RE, Schneider D, Hammerle CH. Guided bone regeneration and abutment connection augment the buccal soft tissue contour: 3-year results of a prospective comparative clinical study. Clin Oral Implants Res. 2017 Feb;28(2):219-225. doi: 10.1111/clr.12786. Epub 2016 Feb 8.

  PMID: 26856399 BACKGROUND

• Pirc M, Harbeck O, Sapata VM, Husler J, Jung RE, Hammerle CHF, Thoma DS. Contour changes of peri-implant tissues are minimal and similar for a one- and a two-piece implant system over 12 years. Clin Oral Investig. 2021 Feb;25(2):719-727. doi: 10.1007/s00784-020-03638-1. Epub 2020 Oct 15.

  PMID: 33063219 BACKGROUND

• Liu Z, Yu X, Ma B, Yang Y, Mu Y, Lu X, Li M, Jing W, Wei P, Ma S, Zhao B, Deng J. SIS membrane modification to improve antimicrobial and osteogenic properties for guide bone regeneration. J Biomater Sci Polym Ed. 2023 Aug;34(10):1337-1359. doi: 10.1080/09205063.2023.2166337. Epub 2023 Jan 17.

  PMID: 36607605 BACKGROUND

• Liu Z, Wei P, Cui Q, Mu Y, Zhao Y, Deng J, Zhi M, Wu Y, Jing W, Liu X, Zhao J, Zhao B. Guided bone regeneration with extracellular matrix scaffold of small intestinal submucosa membrane. J Biomater Appl. 2022 Nov;37(5):805-813. doi: 10.1177/08853282221114450. Epub 2022 Aug 4.

  PMID: 35924456 BACKGROUND

• Qian SJ, Pu YP, Zhang XM, Wu XY, Liu BL, Lai HC, Shi JY. Clinical, radiographic, and esthetic evaluation of immediate implant placement with buccal bone dehiscence in the anterior maxilla: A 1-year prospective case series. Clin Implant Dent Relat Res. 2023 Feb;25(1):3-10. doi: 10.1111/cid.13154. Epub 2022 Nov 14.

  PMID: 36373737 BACKGROUND

• Cairo F, Nieri M, Cavalcanti R, Landi L, Rupe A, Sforza NM, Pace R, Barbato L. Marginal soft tissue recession after lateral guided bone regeneration at implant site: A long-term study with at least 5 years of loading. Clin Oral Implants Res. 2020 Nov;31(11):1116-1124. doi: 10.1111/clr.13658. Epub 2020 Sep 23.

  PMID: 32875633 BACKGROUND

• Dard M, Shiota M, Sanda M, Yajima Y, Sekine H, Kasugai S. A randomized, 12-month controlled trial to evaluate non-inferiority of early compared to conventional loading of modSLA implants in single tooth gaps. Int J Implant Dent. 2016 Dec;2(1):10. doi: 10.1186/s40729-016-0040-8. Epub 2016 Apr 4.

  PMID: 27747702 BACKGROUND

• Alshhrani WM, Al Amri MD. Customized CAD-CAM healing abutment for delayed loaded implants. J Prosthet Dent. 2016 Aug;116(2):176-9. doi: 10.1016/j.prosdent.2016.01.024. Epub 2016 Mar 30.

  PMID: 27038526 BACKGROUND

• Gan LM, Zhou QR, Zhang Y, Yu YC, Yu ZZ, Sun Y, Li RX, Wu XW, Yang F. Alveolar Bone Morphologic Predictors for Guided Bone Regeneration Outcome in Anterior Maxilla. Int Dent J. 2024 Feb;74(1):102-109. doi: 10.1016/j.identj.2023.07.007. Epub 2023 Sep 14.

  PMID: 37714716 BACKGROUND

• ElAskary A, Elfana A, Meabed M, Abd-ElWahab Radi I, Akram M, Fawzy El-Sayed K. Immediate implant placement utilizing vestibular socket therapy versus early implant placement with contour augmentation for rehabilitation of compromised extraction sockets in the esthetic zone: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2022 Oct;24(5):559-568. doi: 10.1111/cid.13120. Epub 2022 Jul 10.

  PMID: 35811090 BACKGROUND

• Zuercher AN, Strauss FJ, Paque PN, Bienz SP, Jung RE, Thoma DS. Randomized controlled pilot study comparing small buccal defects around dental implants treated with a subepithelial connective tissue graft or with guided bone regeneration. Clin Oral Implants Res. 2023 Oct;34(10):1094-1105. doi: 10.1111/clr.14140. Epub 2023 Jul 23.

  PMID: 37483129 BACKGROUND

• Basler T, Naenni N, Schneider D, Hammerle CHF, Jung RE, Thoma DS. Randomized controlled clinical study assessing two membranes for guided bone regeneration of peri-implant bone defects: 3-year results. Clin Oral Implants Res. 2018 May;29(5):499-507. doi: 10.1111/clr.13147. Epub 2018 Apr 15.

  PMID: 29656495 BACKGROUND

• Naenni N, Stucki L, Husler J, Schneider D, Hammerle CHF, Jung RE, Thoma DS. Implants sites with concomitant bone regeneration using a resorbable or non-resorbable membrane result in stable marginal bone levels and similar profilometric outcomes over 5 years. Clin Oral Implants Res. 2021 Aug;32(8):893-904. doi: 10.1111/clr.13764. Epub 2021 Jun 4.

  PMID: 33977571 BACKGROUND

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Chao Liang, PhD

  Beijing Stomatological Hospital, Capital Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Department of Dental Implant Center

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: April 30, 2023
• Primary Completion: August 2, 2024
• Study Completion: August 16, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)