Clinical trial NCT06654141: Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets
Official title: Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Loss
Keywords: ridge preservation
tooth extraction
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2024-10-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
timeFrame: 3 months
measure: Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months)
timeFrame: 3 months
measure: Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months)
timeFrame: 6 months
measure: Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)
timeFrame: 2 weeks following tooth extraction and alveolar ridge preservation
measure: Assessment of the mucosal healing after implant placement at 2 weeks using a wound healing index (1-3 scale rating)
timeFrame: 2 weeks after dental implant placement
measure: Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction
timeFrame: At the time of implant placement (3 or 6 months)
measure: Patient reported outcomes (number of days of total or partially impaired activity) following implant placement
timeFrame: 4 months post implant placement
measure: Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100)
timeFrame: 2 weeks following tooth extraction and alveolar ridge preservation
measure: Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100)
timeFrame: 3 months following tooth extraction and alveolar ridge preservation
measure: Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100)
timeFrame: 6 months following tooth extraction and alveolar ridge preservation
measure: Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100)
timeFrame: Up to 30 days post implant crown delivery
measure: Implant survival rate
timeFrame: 1 year post implant loading
measure: Marginal bone level changes
timeFrame: 1 year post implant loading
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.