Tooth LossNCT06654141
Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets
A study testing Alveolar ridge preservation in people with Tooth Loss, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital
Shanghai, 201999
Xinbo Yu, BDS, 86+23271699 ext. 6057, xinboyu@proton.me
About this study
Official title: Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: a Randomized Controlled Trial
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.
Read more
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
- Being tested
- Alveolar ridge preservation
- Keywords
- ridge preservation, tooth extraction
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservationProcedure or surgery
Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months)
| Study group | Role | What they receive |
|---|---|---|
| Implant placement 3 months after tooth extraction | Experimental | Alveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 3 months after tooth extraction Receives: 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 Receives: Procedure: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
Percentage of vital bone
Measured: 3 months
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months
Percentage of vital bone
Measured: 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)
Clinical and radiographic (via CBCT) assessment. The buccal-lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (3-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.
Measured: 3 months
Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months)
Clinical and radiographic (via CBCT) assessment. The buccal-lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (6-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.
Measured: 6 months
Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)
Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Measured: 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)
Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration
Measured: 2 weeks after dental implant placement
Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction
Number of days of total or partially impaired activity
Measured: At the time of implant placement (3 or 6 months)
Patient reported outcomes (number of days of total or partially impaired activity) following implant placement
Number of days of total or partially impaired activity
Measured: 4 months post implant placement
Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Measured: 2 weeks following tooth extraction and alveolar ridge preservation
Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Measured: 3 months following tooth extraction and alveolar ridge preservation
Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100)
Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").
Measured: 6 months following tooth extraction and alveolar ridge preservation
Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100)
Patients will be asked to rate their satisfaction in terms of function, comfort and esthetics, using a Visual Analog Scale (0-100, with 0 meaning "not at satisfied at all" and 100 corresponding to "perfectly satisfied").
Measured: Up to 30 days post implant crown delivery
Implant survival rate
Percentage of implants still in the mouth
Measured: 1 year post implant loading
Marginal bone level changes
Measured in millimeters using standardized parallel technique intraoral radiographs
Measured: 1 year post implant loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start6 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654141
- Sponsor's protocol ID
- SDC-2024-1
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24966231Dai 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.
PubMed 38884702Ben 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.
PubMed 33316099Zellner 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.
PubMed 36527199Couso-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.
PubMed 36345818
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06654141
- Acronym / sponsor ID
- SDC-2024-1
- Conditions
- Tooth Loss
- Keywords
- ridge preservation, tooth extraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant placement 3 months after tooth extraction | Experimental | Procedure: Alveolar ridge preservationAlveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 3 months after tooth extraction |
| Implant placement 6 months after tooth extraction | Active comparator | Procedure: Alveolar ridge preservationAlveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement 6 months after tooth extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar ridge preservationAlveolar ridge preservation using xenograft (Bio-Oss Collagen®) and implant placement at 2 different time intervals (3 and 6 months) | Procedure or surgery | Implant placement 3 months after tooth extraction, Implant placement 6 months after tooth extraction |
Primary outcome
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months
Time frame: 3 months
Percentage of vital bone
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 6 months
Time frame: 6 months
Percentage of vital bone
12 secondary outcomes
Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (3 months)
Time frame: 3 months
Linear dimensional alterations of the alveolar ridge from the time of tooth extraction to the time of implant placement (6 months)
Time frame: 6 months
Assessment of the mucosal healing of the extraction sites at 2 weeks using a wound healing index (1-3 scale rating)
Time frame: 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)
Time frame: 2 weeks after dental implant placement
Patient reported outcomes (number of days of total or partially impaired activity) following tooth extraction
Time frame: At the time of implant placement (3 or 6 months)
Patient reported outcomes (number of days of total or partially impaired activity) following implant placement
Time frame: 4 months post implant placement
Patient reported outcomes (pain) 2 weeks following tooth extraction, using a Visual Analog Score for pain (0-100)
Time frame: 2 weeks following tooth extraction and alveolar ridge preservation
Patient reported outcomes (pain) 3 months following tooth extraction, using a Visual Analog Score for pain (0-100)
Time frame: 3 months following tooth extraction and alveolar ridge preservation
Patient reported outcomes (pain) 6 months following tooth extraction, using a Visual Analog Score for pain (0-100)
Time frame: 6 months following tooth extraction and alveolar ridge preservation
Patient reported outcomes (patient satisfaction), using a Visual Analog Scale (0-100)
Time frame: Up to 30 days post implant crown delivery
Implant survival rate
Time frame: 1 year post implant loading
Marginal bone level changes
Time frame: 1 year post implant loading
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 24966231Avila-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.
- Background: PubMed 38884702Dai 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.
- Background: PubMed 33316099Ben 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.
- Background: PubMed 36527199Zellner 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.
- Background: PubMed 36345818Couso-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation in people with Tooth Loss, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinbo Yu, BDS (86+23271699 ext. 6057, xinboyu@proton.me), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of vital bone via histomorphometric evaluation of bone core biopsies at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06654141, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.