Periodontal PocketNCT06318247
Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets
A study testing site preservation in people with Periodontal Pocket and Periodontal Bone Loss, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars. Read more about this study
- Who is it for?
- Ages 26 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket, Periodontal Bone Loss, Impacted Third Molar Tooth
- What is being tested?
- site preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 26 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 26-45 years old
- Completely or partially impacted mandibular third molar
- No evidence of acute inflammation
- In good physical status and oral health
- Regular attendance at control visits
Who cannot join
- pregnancy or lactation
- Aggregate systemic pathologies such as diabetes, thyroid disorders, bone metabolism diseases, among others
- Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with bone metabolism
- Patients with uncontrolled periodontal conditions, endodontic conditions and other oral disorders
- Heavy smoke (10 cigarettes/day or more)
- The second molar has no contact with the third molar, or the third molar crown has alveolar bone
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jue Shi, Doctor, +86 13757171359, dentistsj@zju.edu.cn
About this study
Official title: Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets in the Distal of the Mandibular Second Molar After the Extraction of the Third Molar
To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars.
Read the detailed description
The mandibular third molar is the last tooth to erupt in the dentition, and due to the insufficient eruption position, it can lead to different degrees of impact. During the eruption of impacted tooth, the crown may be partially or completely covered by the gingival flap. A deep blind pocket is formed between the gingival flap and the tooth crown, and food and bacteria are easily impinged in the blind pocket. Under the influence of oral environment and dental plaque, the presence of blind pockets can lead to the loss of periodontal attachment and the absorption of alveolar bone, thus affecting the distal periodontal status of adjacent molars.
Organic bone xenograft material composed of absorbable organic bovine hydroxyapatite is one of the commonly used transplantation materials for repairing bone defects. The application effect of allogeneic bone materials in periodontal therapy has been recognized by many experts and scholars. Guided bone regeneration (GBR), as a conventional periodontal bone graft, has achieved good results in periodontal tissue regeneration. Aljuboori et al. found that when the third molar was removed and GBR was performed at the same time, the depth of distal periodontal pocket probing of the adjacent second molar was significantly reduced in the re-examination 6 months after surgery.
Hence, this study intends to use xenograft combined with barrier membrane to improve the formation of distal periodontal pocket of the second molars after third molars extraction.
- Being tested
- site preservation
- Medical subject headings
- Periodontal Pocket, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
site preservationProcedure or surgery
Tooth extraction of third molars with site preservation using bio-oss (0.5g, Small granule) and bio-guide (25*25mm size). The bone graft material used in the surgical procedure was provided by Geistlich Pharma AG.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Tooth extraction of third molars Receives: Procedure: site preservation |
| GBR group | Experimental | Tooth extraction of third molars with site preservation using bio-oss (0.5g, Small granule) and bio-guide (25*25mm size). The bone graft material used in the surgical procedure was provided by Geistlich Pharma AG. Receives: Procedure: site preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depths (PPD)
The depth of the periodontal pocket is examined with a periodontal probe. Probing pocket depths (PPD) measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML) in postoperative 14days, 3, 6 and 12 months. The distal measurements are the primary outcomes. The higher the value, the worse the periodontal condition.
Measured: postoperative 14 days, 3 6 and 12 months
Distal bone wall defect (DBWD)
The height of distal bone wall defect of the second mandibular molar is measured by cone-beam CT.
Measured: postoperative 14 days, 3 6 and 12 months
Clinical attachment lose (CAL)
clinical attachment lose (CAL) were measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML). The distal measurements are the primary outcomes.
Measured: postoperative 14 days, 3 6 and 12 months
Bleeding on probing (BOP)
Periodontal probing for bleeding can determine whether the gingiva is in a state of inflammation or whether periodontal disease is in an active phase.
Measured: postoperative 14 days, 3 6 and 12 months
Secondary outcomes (3)
Pain score
Visual Analog Score for pain
Measured: pre-operation, postoperative 14 days, 3 6 and 12 months
Patient satisfaction
Physicians Global Assessment to measure quality of life
Measured: pre-operation, postoperative 14 days, 3 6 and 12 months
Gingival index (GI)
The higher the index, the worse the periodontal condition.
Measured: pre-operation, postoperative 14 days, 3 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318247
- Sponsor's protocol ID
- 2022-134(R)
- Status last verified
- Mar 2024
- First submitted
- 27 Aug 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets in the Distal of the Mandibular Second Molar After the Extraction of the Third Molar
- ClinicalTrials.gov ID
- NCT06318247
- Acronym / sponsor ID
- 2022-134(R)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Mar 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.
To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars.
Detailed description
The mandibular third molar is the last tooth to erupt in the dentition, and due to the insufficient eruption position, it can lead to different degrees of impact. During the eruption of impacted tooth, the crown may be partially or completely covered by the gingival flap. A deep blind pocket is formed between the gingival flap and the tooth crown, and food and bacteria are easily impinged in the blind pocket. Under the influence of oral environment and dental plaque, the presence of blind pockets can lead to the loss of periodontal attachment and the absorption of alveolar bone, thus affecting the distal periodontal status of adjacent molars.
Organic bone xenograft material composed of absorbable organic bovine hydroxyapatite is one of the commonly used transplantation materials for repairing bone defects. The application effect of allogeneic bone materials in periodontal therapy has been recognized by many experts and scholars. Guided bone regeneration (GBR), as a conventional periodontal bone graft, has achieved good results in periodontal tissue regeneration. Aljuboori et al. found that when the third molar was removed and GBR was performed at the same time, the depth of distal periodontal pocket probing of the adjacent second molar was significantly reduced in the re-examination 6 months after surgery.
Hence, this study intends to use xenograft combined with barrier membrane to improve the formation of distal periodontal pocket of the second molars after third molars extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: site preservationTooth extraction of third molars |
| GBR group | Experimental | Procedure: site preservationTooth extraction of third molars with site preservation using bio-oss (0.5g, Small granule) and bio-guide (25*25mm size). The bone graft material used in the surgical procedure was provided by Geistlich Pharma AG. |
Who may qualify
- Ages
- 26 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 26-45 years old
- Completely or partially impacted mandibular third molar
- No evidence of acute inflammation
- In good physical status and oral health
- Regular attendance at control visits
Key exclusion criteria (6 listed)
- pregnancy or lactation
- Aggregate systemic pathologies such as diabetes, thyroid disorders, bone metabolism diseases, among others
- Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with bone metabolism
- Patients with uncontrolled periodontal conditions, endodontic conditions and other oral disorders
- Heavy smoke (10 cigarettes/day or more)
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 |
|---|---|---|
| site preservationTooth extraction of third molars with site preservation using bio-oss (0.5g, Small granule) and bio-guide (25*25mm size). The bone graft material used in the surgical procedure was provided by Geistlich Pharma AG. | Procedure or surgery | Control group, GBR group |
Primary outcome
Probing pocket depths (PPD)
Time frame: postoperative 14 days, 3 6 and 12 months
The depth of the periodontal pocket is examined with a periodontal probe. Probing pocket depths (PPD) measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML) in postoperative 14days, 3, 6 and 12 months. The distal measurements are the primary outcomes. The higher the value, the worse the periodontal condition.
Distal bone wall defect (DBWD)
Time frame: postoperative 14 days, 3 6 and 12 months
The height of distal bone wall defect of the second mandibular molar is measured by cone-beam CT.
Clinical attachment lose (CAL)
Time frame: postoperative 14 days, 3 6 and 12 months
clinical attachment lose (CAL) were measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML). The distal measurements are the primary outcomes.
Bleeding on probing (BOP)
Time frame: postoperative 14 days, 3 6 and 12 months
Periodontal probing for bleeding can determine whether the gingiva is in a state of inflammation or whether periodontal disease is in an active phase.
3 secondary outcomes
Pain score
Time frame: pre-operation, postoperative 14 days, 3 6 and 12 months
Patient satisfaction
Time frame: pre-operation, postoperative 14 days, 3 6 and 12 months
Gingival index (GI)
Time frame: pre-operation, postoperative 14 days, 3 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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. This study is not recruiting at the moment.
Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing site preservation in people with Periodontal Pocket and Periodontal Bone Loss, run by The Dental Hospital of Zhejiang University School of Medicine 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depths (PPD) (time frame: postoperative 14 days, 3 6 and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2024.