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

NCT ID: NCT06574815

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2024-08-16

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.

Detailed Description

Patients were randomized into three groups at a 1:1:1 ratio, including the GBR with a Bio-Gide membrane and delayed implant loading (Gide-DL) group, the GBR with a Bio-Gide membrane and early implant loading (Gide-EL) group, and the GBR with an SIS membrane and early implant loading (SIS-EL) group. The allocation sequence was generated through an online tool (www. random.org) and was concealed in sealed envelopes. At 6 weeks after implant and GBR surgery, the implant stability quotient (ISQ) was measured and recorded at the labial, palatal, mesial, and distal locations via the Osstell device in the Gide-EL group and the SIS-EL group. If the ISQ was ≥ 65, definitive restoration (early loading) was performed (if < 65, the subject was withdrawn from the trial). The digital impressions and occlusal relationships were obtained via intraoral scanning, and the implant-supported crown was designed based on the digital model. Titanium base abutments with angled screw channels (ASCs) and porcelain veneered zirconia (PVZ) crowns were used for restoration. Immediately after definitive restoration, intraoral scanning was used to record the soft tissue contour at the implant site, and CBCT was used to examine the bone tissue around the implant. In addition, patients in the Gide-DL group underwent definitive restoration at 6 months after surgery (delayed loading), and the treatment process was the same as that in the Gide-EL and SIS-EL groups at 6 weeks after surgery. Clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring were used to determine the clinical effect of SIS membranes and early implant loading at 1-year follow-up.

Conditions

Dental Implantation; Guided Bone Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SIS-EL

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

Group Type: EXPERIMENTAL

Early implant loading

Intervention Type: PROCEDURE

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

GBR using an SIS membrane

Intervention Type: PROCEDURE

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

Gide-EL

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

Group Type: ACTIVE_COMPARATOR

Early implant loading

Intervention Type: PROCEDURE

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

GBR using an Bio-Gide membrane

Intervention Type: PROCEDURE

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

Gide-DL

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

Group Type: SHAM_COMPARATOR

Delayed implant loading

Intervention Type: PROCEDURE

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

GBR using an Bio-Gide membrane

Intervention Type: PROCEDURE

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

Interventions

Early implant loading

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

Intervention Type: PROCEDURE

Delayed implant loading

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

Intervention Type: PROCEDURE

GBR using an SIS membrane

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

Intervention Type: PROCEDURE

GBR using an Bio-Gide membrane

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Stomatological Hospital, Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chao Liang

Doctor of Department of Dental Implant Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chao Liang, PhD

Role: STUDY_DIRECTOR

Beijing Stomatological Hospital, Capital Medical University

Locations

Beijing Stomatological Hospital, Capital Medical University

Beijing, , China

Countries

China

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Other Identifiers

CSA-SIS2022-17

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CMUSH-IRB-KJ-PJ-2023-24

Identifier Type: -

Identifier Source: org_study_id