Alveolar Bone ResorptionNCT04239378
Comparison of Autogenous Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation
A study testing socket preservation in people with Alveolar Bone Resorption, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(DDM) versus bovine derived xenograft(DBM) for socket preservation procedure. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 10 Dec 2019to Nov 2021
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Teeth indicated for extraction and subsequent implant placement
- Age group of 18 to 55 years
- Single rooted tooth indicated for extraction due to endodontic failure, caries or Fracture
- Presence of >2 mm keratinized tissue to allow flap management
- Extraction site should have adjacent tooth on either side
- Systemically healthy patients
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- Class II or III extraction socket defects according to Hammerele and Jung(2008)
- Full mouth plaque score(FMPS)<25% at baseline.(PI)
- Full mouth bleeding score(FMBS)<25% at baseline. (BI)
Who cannot join
- .Presence of dehiscence or fenestration in any of the socket, more than 50% of bone loss in any of the socket walls
- Medical conditions contraindicating surgical interventions
- Known smokers and alcoholics
- Subjects with known bone metabolic disorders.(Pagets disease,fibrous dysplasia etc.)
- Acute infections at the site of extraction. Eg , Abscess
- History of malignancy
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- Patients who have undergone radiotherapy or chemotherapy
- Periapical pathology such as granulomas, cyst, hypercementosis, ankylosis.
- Pregnant and lactating women
- Maxillary and mandibular 3rd molars.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Krishnadevaray College of Dental Science and Hospital
Bangalore, Karnataka, 562157
salma banu, MDS, 8792625900 ext. +91, salmaakram200931@gmail.com
About this study
Official title: Clinical, Radiographic and Histomorphometric Comparison of Autogenous Demineralized Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation: A Randomised Controlled Clinical Trial
The present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(DDM) versus bovine derived xenograft(DBM) for socket preservation procedure.
Read the detailed description
- After local anesthesia a full thickness flap will be minimally reflected buccally and lingually around the tooth not exceeding 3mm apical to the alveolar crest.
- Tooth extraction will be performed using atraumatic extraction methods using Periotome.
- After extraction, the socket will be thoroughly curetted, inspected and irrigated with sterile saline solution.
- The socket satisfying the inclusion and exclusion criteria will be randomly allocated to either test or control group.
- Intra surgical measurements will be recorded.
- Socket preservation will be performed with either Demineralized dentin matrix DDM(TEST) or bovine derived xenograft DBM (CONTROL). Bone graft will be extended to the height of intra proximal bone.
- Collagen membrane will be placed over the grafted site extending approximately 3mm apical to buccal and lingual crest.
- Flaps will be approximated with sutures.
- Conditions
- Alveolar Bone Resorption
- Being tested
- socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket preservationProcedure or surgery
Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)
| Study group | Role | What they receive |
|---|---|---|
| Test group -Autogenous dentin matrix and collagen membrane | Experimental | Test group - After atraumatic tooth extraction , socket will be augmented with autogenous dentin matrix and covered with collagen membrane and sutures are placed. Receives: Procedure: socket preservation |
| Control group-bovine derived xenograft and collagen membrane | Active comparator | control group- After atraumatic tooth extraction, socket will be augmented with bovine derived xenograft and covered with collagen membrane and sutures are placed. Receives: Procedure: socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of Alveolar Crest and Bucco-Lingual Ridge Width
Using Mapping Caliper and (University of North Carolina) UNC- 15 PROBE Measured in mm
Measured: 6 Months
Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG)
CBCT (Cone Beam Computer Tomography) measured in mm
Measured: 6 MONTHS
New Bone Formation % and Residual Bone Graft
HISTOMORPHOMETRIC
Measured: 6 MONTHS
Secondary outcomes (3)
Plaque Index
Silness and Leo index using UNC-15 PROBE with Rating Score Excellent- 0 Good- 0.1 - 0.9 Fair -1.0 - 1.9 Poor - 2.0 - 3.0
Measured: 6months
Bleeding Index
Mombelli - Sulcus Bleeding Index using UNC-15 Probe with Rating Score 0- No bleeding
1 -Isolated bleeding spots visible 2-Blood forms a confluent red line on the margin 3- Heavy or profuse bleeding
Measured: 6 months
Patient Reported Outcome Measures for Pain and Esthetics
( Visual Analog Scale -VAS) Rating score, None (0) Mild (1-3) Moderate (4-6) Severe (7-10)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start10 Dec 2019
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
- Investigators
- DR.JOANN PAULINE GEORGE, MDS, Principal investigator, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239378
- Sponsor's protocol ID
- 02_D012_101639
- Status last verified
- Jan 2020
- First submitted
- 27 Dec 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histomorphometric Comparison of Autogenous Demineralized Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04239378
- Acronym / sponsor ID
- 02_D012_101639
- Conditions
- Alveolar Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 27 Jan 2020 (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 present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(DDM) versus bovine derived xenograft(DBM) for socket preservation procedure.
Detailed description
- After local anesthesia a full thickness flap will be minimally reflected buccally and lingually around the tooth not exceeding 3mm apical to the alveolar crest.
- Tooth extraction will be performed using atraumatic extraction methods using Periotome.
- After extraction, the socket will be thoroughly curetted, inspected and irrigated with sterile saline solution.
- The socket satisfying the inclusion and exclusion criteria will be randomly allocated to either test or control group.
- Intra surgical measurements will be recorded.
- Socket preservation will be performed with either Demineralized dentin matrix DDM(TEST) or bovine derived xenograft DBM (CONTROL). Bone graft will be extended to the height of intra proximal bone.
- Collagen membrane will be placed over the grafted site extending approximately 3mm apical to buccal and lingual crest.
- Flaps will be approximated with sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group -Autogenous dentin matrix and collagen membrane | Experimental | Procedure: socket preservationTest group - After atraumatic tooth extraction , socket will be augmented with autogenous dentin matrix and covered with collagen membrane and sutures are placed. |
| Control group-bovine derived xenograft and collagen membrane | Active comparator | Procedure: socket preservationcontrol group- After atraumatic tooth extraction, socket will be augmented with bovine derived xenograft and covered with collagen membrane and sutures are placed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Teeth indicated for extraction and subsequent implant placement
- Age group of 18 to 55 years
- Single rooted tooth indicated for extraction due to endodontic failure, caries or Fracture
- Presence of >2 mm keratinized tissue to allow flap management
- Extraction site should have adjacent tooth on either side
Key exclusion criteria (10 listed)
- .Presence of dehiscence or fenestration in any of the socket, more than 50% of bone loss in any of the socket walls
- Medical conditions contraindicating surgical interventions
- Known smokers and alcoholics
- Subjects with known bone metabolic disorders.(Pagets disease,fibrous dysplasia etc.)
- Acute infections at the site of extraction. Eg , Abscess
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 |
|---|---|---|
| socket preservationAutogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group) | Procedure or surgery | Control group-bovine derived xenograft and collagen membrane, Test group -Autogenous dentin matrix and collagen membrane |
Primary outcome
Height of Alveolar Crest and Bucco-Lingual Ridge Width
Time frame: 6 Months
Using Mapping Caliper and (University of North Carolina) UNC- 15 PROBE Measured in mm
Alveolar Ridge Width Gain(ARWG) and Vertical Bone Height Gain(VBHG)
Time frame: 6 MONTHS
CBCT (Cone Beam Computer Tomography) measured in mm
New Bone Formation % and Residual Bone Graft
Time frame: 6 MONTHS
HISTOMORPHOMETRIC
3 secondary outcomes
Plaque Index
Time frame: 6months
Bleeding Index
Time frame: 6 months
Patient Reported Outcome Measures for Pain and Esthetics
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Alveolar Bone Resorption
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
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The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
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.
DR.JOANN PAULINE GEORGE, MDS principal investigator
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing socket preservation in people with Alveolar Bone Resorption, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 9 inclusion and 10 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 5 Feb 2020. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.JOANN PAULINE GEORGE, MDS (9448541637, drjoannpaulinegeorge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height of Alveolar Crest and Bucco-Lingual Ridge Width (time frame: 6 Months). The study lists 3 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 5 Feb 2020.