Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets

NCT06654141 | Recruiting DMC

• 1 other identifier: SDC-2024-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to histologically, clinically, and radiographically evaluate the healing sequelae of periodontally compromised extraction sockets grafted with Bio-Oss Collagen® at 3 and 6 months following tooth extraction in molar sites. The main question it aims to answer is: Does healing time influence the histologic, clinical, and radiographic outcomes following socket grafting (alveolar ridge preservation) in periodontally compromised extraction sockets. Researchers will compare a healing time of 3 months to a healing time of 6 months (conventional healing duration) to see if a shorter duration is viable for implant placement. Participants will: Take a cone-beam computed tomography (CBCT) scan to prepare for the surgical procedure. Undergo tooth extraction and the extraction socket will be grafted with Bio-Oss Collagen® and a collagen membrane Bio-Gide® will be placed to stabilize the graft material. Return at 2 weeks for suture removal and either 3- or 6-months post-extraction for implant placement. Return at 2 weeks post-implant placement for suture removal, 3 months for prosthesis fabrication, 4 months for final prosthesis loading, and 1 year post-loading.

Conditions

Tooth Loss

Keywords

ridge preservation; tooth extraction

Outcome Measures

Primary Outcomes (2)

• Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months

  Percentage of vital bone

  3 months

• Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months

  Percentage of vital bone

  6 months

Secondary Outcomes (12)

• Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months)

  3 months

• Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months)

  6 months

• Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)

  2 weeks following tooth extraction and alveolar ridge preservation

• Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating)

  2 weeks after dental implant placement

• Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction

  At the time of implant placement (3 or 6 months)

Study Arms (2)

Implant placement 3 months after tooth extraction

EXPERIMENTAL

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 3 months after tooth extraction

Procedure: Alveolar ridge preservation

Implant placement 6 months after tooth extraction

ACTIVE COMPARATOR

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 6 months after tooth extraction

Procedure: Alveolar ridge preservation

Interventions

Alveolar ridge preservation PROCEDURE

Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)

Implant placement 3 months after tooth extraction; Implant placement 6 months after tooth extraction

Eligibility Criteria

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

You may qualify if:

• years of age or older
• ASA (American Society of Anesthesia) status I or II
• Need for molar extraction due to periodontal disease with or without chronic endodontic involvement, complying with the presentation of periodontitis stage III/IV
• Radiographic evidence of a bone dehiscence on at least one socket wall, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is \>50% of the corresponding root length as measured on CBCT scans prior to extraction (Ben Amara et al., 2021)
• Radiographic evidence of at least 3 mm of residual bone wall height
• Presence of at least one adjacent tooth to the extraction site
• Treatment plan must include tooth replacement with an implant-supported fixed dental prosthesis

You may not qualify if:

• Extraction of multiple adjacent teeth
• Acute infection associated with the tooth to be extracted or with adjacent teeth
• Current smokers (\>10 cigarettes per day)
• Uncontrolled diabetes mellitus (HbA1c \>7.0)
• Any active oral or systemic acute infections
• Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
• Diseases or medications that may compromise normal wound healing

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, 201999, China

RECRUITING

Related Publications (5)

• Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.

  PMID: 24966231 BACKGROUND

• Dai A, Li HY, Kang S, Lin R, Huang JP, Mao F, Ding PH. Effect of alveolar ridge preservation at periodontally compromised molar extraction sockets: A retrospective cohort study. J Periodontol. 2025 Jan;96(1):9-20. doi: 10.1002/JPER.24-0064. Epub 2024 Jun 17.

  PMID: 38884702 BACKGROUND

• Ben Amara H, Kim JJ, Kim HY, Lee J, Song HY, Koo KT. Is ridge preservation effective in the extraction sockets of periodontally compromised teeth? A randomized controlled trial. J Clin Periodontol. 2021 Mar;48(3):464-477. doi: 10.1111/jcpe.13412. Epub 2021 Jan 19.

  PMID: 33316099 BACKGROUND

• Zellner JW, Allen HT, Kotsakis GA, Mealey BL. Wound healing after ridge preservation: A randomized controlled trial on short-term (4 months) versus long-term (12 months) histologic outcomes. J Periodontol. 2023 May;94(5):622-629. doi: 10.1002/JPER.22-0187. Epub 2023 Jan 10.

  PMID: 36527199 BACKGROUND

• Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.

  PMID: 36345818 BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Xinbo Yu, BDS

CONTACT

86+23271699; xinboyu@proton.me

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 19, 2025

Record last verified: 2024-10

Locations

CN (1)