Clinical trial NCT05902689: Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation
Official title: Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Resorption
Keywords: alveolar ridge preservation
Bio-OSS Collagen
sticky bone
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group underwent natural healing, and the experimental group underwent alveolar ridge preservation using Bio-Oss Collagen and Sticky Bone, respectively.
Primary purpose: TREATMENT

Brief summary: In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the control group underwent alveolar ridge preservation using Bio-Oss Collagen and the experimental group using Sticky Bone, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation

Detailed description: Within 6 months after tooth extraction, the remaining alveolar ridge undergoes varying degrees of absorption, resulting in a decrease in horizontal width and vertical height of the alveolar ridge. The three-dimensional size change of the alveolar socket may affect the implantation of later implants and cause aesthetic and functional problems. Alveolar ridge preservation can maintain the volume of the alveolar socket, prevent soft tissue from growing into undesirable positions, slow down the absorption of the alveolar ridge to some extent, promote new bone formation, and maintain the shape of the extraction socket. This is crucial for later implant treatment for missing teeth. In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the control group underwent alveolar ridge preservation using Bio-Oss Collagen and the experimental group using Sticky Bone, respectively, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation

Eligibility criteria: Inclusion Criteria:

1. The presence of one adjacent tooth at the extraction site
2. Adequate oral hygiene (plaque index \<20%;bleeding on probing \<25% )
3. Need for tooth extraction due to endodontic，periapical or periodontal disease.
4. Presence of ≥ 2 mm of keratinized tissue
5. the extraction sockets have no more than 50% of buccal alveolar bone loss(Integrity of alveolar bone walls)

Exclusion Criteria:

1. Pregnancy or lactation
2. Smoking more than 10 cigarettes per day
3. with no evidence of acute infection such as severe swelling, suppuration at the extraction site
4. Uncontrolled periodontal disease
5. Existence of bone metabolic disease
6. history of malignancy, radiotherapy, or chemotherapy in the past 5 years
7. Administration of bisphosphonates
8. long-term use of NSAIDs
9. Alcohol or drug abuse
10. Infectious disease, such as hepatitis or human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome (AIDS)
11. Uncontrolled severe diabetes.( hemoglobin A1c \>6.7%)

Primary outcomes:
measure: Changes in horizontal ridge widths
timeFrame: baseline (before the surgery) and six months
Secondary outcomes:
measure: Changes in the vertical heights of the ridge
timeFrame: baseline (before the surgery) and six months
measure: Thicknesses of the keratinized gingiva
timeFrame: baseline (before the surgery) and six months
measure: width of the keratinized gingiva
timeFrame: baseline (before the surgery) and six months
measure: percentages of newly formed bone
timeFrame: six months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Li Li Zhou, doctor
role: STUDY_DIRECTOR
References: