Tooth ExtractionLaminaNCT07231874
Cortical Lamina for Alveolar Ridge Preservation
A study testing Cortical Lamina Technique in people with Tooth Extraction and Periapical Infections, run by ARDEC Academy at 1 site in Cuba.
Trial summary
This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated flap and buccal bone plate following tooth extraction for preserving alveolar ridge dimensions. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction, Periapical Infections, Tooth Fracture
- What is being tested?
- Cortical Lamina Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCuba
- Study dates
- 1 Apr 2024to 1 Oct 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of a tooth indicated for extraction (maxillary incisors, canines, or premolars in either jaw).
- Age ≥ 21 years.
- Good general health with no contraindications for oral surgery.
- Non-pregnant individuals.
- Willingness to participate and sign written informed consent.
Who cannot join
- Uncontrolled systemic disease (e.g., diabetes mellitus, hypertension).
- History of chemotherapy or radiotherapy.
- Current smokers of more than 10 cigarettes per day.
- Sites previously treated with regenerative or augmentation procedures.
- Poor oral hygiene or active periodontal infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preservation of the Alveolar Ridge Using a Cortical Lamina After Tooth Extraction: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated flap and buccal bone plate following tooth extraction for preserving alveolar ridge dimensions. Forty patients will be randomly assigned to either the test group (lamina placement) or control (no intervention). Changes in ridge width and height will be assessed using CBCT and 3D digital models after six months.
Read the detailed description
Alveolar bone resorption after tooth extraction can compromise prosthetic and implant rehabilitation by reducing both bone height and width, especially at the buccal plate. Various alveolar ridge preservation (ARP) techniques have been proposed to minimize these dimensional changes; however, their clinical predictability and long-term benefit remain debated.
This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated mucoperiosteal flap and the buccal bone plate immediately after tooth extraction to preserve alveolar ridge dimensions. The technique is intended to limit post-extraction resorption by temporarily isolating the periosteum from the underlying bone, promoting favorable bone remodeling and contour maintenance for subsequent implant placement.
Forty patients requiring the extraction of single teeth (premolars, canines, or maxillary incisors) will be enrolled and randomly allocated into two groups:
Test group: A cortical lamina will be inserted between the buccal bone and the flap following tooth extraction.
Control group: Extraction sites will be left untreated to heal spontaneously.
All surgeries will be performed under local anesthesia by calibrated clinicians. Healing will occur by primary intention without submerged flaps. Sutures will be removed after two weeks. Patients will follow standardized postoperative care, including chlorhexidine rinses and analgesics as needed.
Cone-beam computed tomography (CBCT) and digital impressions will be obtained at baseline (immediately post-extraction) and at six months. The primary outcome is the linear change in ridge width and height measured on CBCT scans. Secondary outcomes include volumetric dimensional changes analyzed from 3D digital impressions.
Data will be analyzed using parametric or non-parametric tests depending on normal distribution (ANOVA or Kruskal-Wallis, with appropriate post-hoc comparisons). A significance level of p < 0.05 will be applied.
The study follows the Declaration of Helsinki and CONSORT 2010 guidelines. Ethical approval has been granted by the Comité de Ética de la Investigación, Universidad de Ciencias Médicas de La Habana (Aval 2024/01, April 9 2024).
- Conditions
- Tooth Extraction, Periapical Infections, Tooth Fracture, Periodontal Disease, AVDC Stage 4, Hopeless Tooth
- Being tested
- Cortical Lamina Technique, Natural Healing (Control)
- Keywords
- ridge preservation, Cortical Lamina, Bone Regeneration, Alveolar Bone Loss, Tooth extraction, Implant Site Development, Buccal Bone
- Medical subject headings
- Tooth Fractures, Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical Lamina TechniqueProcedure or surgery
Surgical placement of a cortical lamina between the buccal bone plate and elevated mucoperiosteal flap immediately after tooth extraction. The lamina serves as a barrier to stabilize the alveolar contour and promote bone preservation. The flap is sutured for non-submerged healing, and postoperative care includes chlorhexidine rinses and analgesics as needed.
Natural Healing (Control)Procedure or surgery
After tooth extraction, the site will heal naturally without placement of cortical lamina or any grafting material. The flap is repositioned and sutured for non-submerged healing. Postoperative care is identical to the test group.
| Study group | Role | What they receive |
|---|---|---|
| Test Group - Cortical Lamina Placement | Experimental | Following atraumatic tooth extraction, a small full-thickness flap will be elevated without releasing incisions. A cortical lamina will be placed between the buccal bone plate and the elevated flap to isolate the periosteum and stabilize the ridge contour. The flap will then be repositioned and sutured for non-submerged healing. Sutures will be removed after two weeks. Standard postoperative care will include 0.12% chlorhexidine mouth rinses and analgesics as needed. Receives: Procedure: Cortical Lamina Technique |
| Control Group - Spontaneous Healing | Active comparator | After tooth extraction, the site will be allowed to heal naturally without the placement of cortical lamina or any grafting material. The flap will be repositioned and sutured for non-submerged healing. Postoperative care will follow the same protocol as the test group. Receives: Procedure: Natural Healing (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alveolar Ridge Width and Height
Linear dimensional changes in the alveolar ridge (horizontal width and vertical height) will be evaluated using cone-beam computed tomography (CBCT) images taken immediately after tooth extraction (baseline) and six months post-surgery. Measurements will be made at standardized reference points on cross-sectional CBCT slices to quantify resorption or preservation of bone.
Measured: Baseline (immediately post-extraction) to 6 months after extraction
Secondary outcomes (1)
Volumetric Change of the Alveolar Ridge
Volumetric dimensional changes of the alveolar ridge will be assessed by comparing 3D digital models of the extraction sites obtained from intraoral impressions taken at baseline (immediately post-extraction) and six months after surgery. Superimposition and digital analysis will be performed to quantify total volume loss or preservation of the alveolar ridge contour.
Measured: Baseline to 6 months post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Apr 2024
- Primary completion1 Dec 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies 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
- Model description
- Participants will be randomly assigned to one of two parallel groups. In the test group, a cortical lamina will be placed between the elevated mucoperiosteal flap and the buccal bone plate immediately after tooth extraction. In the control group, extraction sockets will heal spontaneously without lamina placement. Both groups will be followed for six months before implant placement to assess dimensional changes in the alveolar ridge.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARDEC Academy
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231874
- Sponsor's protocol ID
- 2024/01
- Acronym
- Lamina
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is conducted at a single clinical center with a limited sample size, and the data contain identifiable clinical imaging and patient information. Aggregated results and summary analyses will be made available through scientific publications and conference presentations.
Publications
Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
PubMed 30623987Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2.
PubMed 26020735Richardson CR, Mellonig JT, Brunsvold MA, McDonnell HT, Cochran DL. Clinical evaluation of Bio-Oss: a bovine-derived xenograft for the treatment of periodontal osseous defects in humans. J Clin Periodontol. 1999 Jul;26(7):421-8. doi: 10.1034/j.1600-051x.1999.260702.x.
PubMed 10412845Lee JH, Yi GS, Lee JW, Kim DJ. Physicochemical characterization of porcine bone-derived grafting material and comparison with bovine xenografts for dental applications. J Periodontal Implant Sci. 2017 Dec;47(6):388-401. doi: 10.5051/jpis.2017.47.6.388. Epub 2017 Dec 31.
PubMed 29333325Klinge B, Alberius P, Isaksson S, Jonsson J. Osseous response to implanted natural bone mineral and synthetic hydroxylapatite ceramic in the repair of experimental skull bone defects. J Oral Maxillofac Surg. 1992 Mar;50(3):241-9. doi: 10.1016/0278-2391(92)90320-y.
PubMed 1311759Al Qabbani A, Al Kawas S, A Razak NH, Al Bayatti SW, Enezei HH, Samsudin AR, Sheikh Ab Hamid S. Three-Dimensional Radiological Assessment of Alveolar Bone Volume Preservation Using Bovine Bone Xenograft. J Craniofac Surg. 2018 Mar;29(2):e203-e209. doi: 10.1097/SCS.0000000000004263.
PubMed 29303859
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of the Alveolar Ridge Using a Cortical Lamina After Tooth Extraction: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07231874
- Acronym / sponsor ID
- Lamina / 2024/01
- Conditions
- Tooth Extraction, Periapical Infections, Tooth Fracture, Periodontal Disease, AVDC Stage 4, Hopeless Tooth
- Keywords
- ridge preservation, Cortical Lamina, Bone Regeneration, Alveolar Bone Loss, Tooth extraction, Implant Site Development, Buccal Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ARDEC AcademyResearch network
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 17 Nov 2025 (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.
This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated flap and buccal bone plate following tooth extraction for preserving alveolar ridge dimensions. Forty patients will be randomly assigned to either the test group (lamina placement) or control (no intervention). Changes in ridge width and height will be assessed using CBCT and 3D digital models after six months.
Detailed description
Alveolar bone resorption after tooth extraction can compromise prosthetic and implant rehabilitation by reducing both bone height and width, especially at the buccal plate. Various alveolar ridge preservation (ARP) techniques have been proposed to minimize these dimensional changes; however, their clinical predictability and long-term benefit remain debated.
This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated mucoperiosteal flap and the buccal bone plate immediately after tooth extraction to preserve alveolar ridge dimensions. The technique is intended to limit post-extraction resorption by temporarily isolating the periosteum from the underlying bone, promoting favorable bone remodeling and contour maintenance for subsequent implant placement.
Forty patients requiring the extraction of single teeth (premolars, canines, or maxillary incisors) will be enrolled and randomly allocated into two groups:
Test group: A cortical lamina will be inserted between the buccal bone and the flap following tooth extraction.
Control group: Extraction sites will be left untreated to heal spontaneously.
All surgeries will be performed under local anesthesia by calibrated clinicians. Healing will occur by primary intention without submerged flaps. Sutures will be removed after two weeks. Patients will follow standardized postoperative care, including chlorhexidine rinses and analgesics as needed.
Cone-beam computed tomography (CBCT) and digital impressions will be obtained at baseline (immediately post-extraction) and at six months. The primary outcome is the linear change in ridge width and height measured on CBCT scans. Secondary outcomes include volumetric dimensional changes analyzed from 3D digital impressions.
Data will be analyzed using parametric or non-parametric tests depending on normal distribution (ANOVA or Kruskal-Wallis, with appropriate post-hoc comparisons). A significance level of p < 0.05 will be applied.
The study follows the Declaration of Helsinki and CONSORT 2010 guidelines. Ethical approval has been granted by the Comité de Ética de la Investigación, Universidad de Ciencias Médicas de La Habana (Aval 2024/01, April 9 2024).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. In the test group, a cortical lamina will be placed between the elevated mucoperiosteal flap and the buccal bone plate immediately after tooth extraction. In the control group, extraction sockets will heal spontaneously without lamina placement. Both groups will be followed for six months before implant placement to assess dimensional changes in the alveolar ridge.
| Arm | Type | Receives |
|---|---|---|
| Test Group - Cortical Lamina Placement | Experimental | Procedure: Cortical Lamina TechniqueFollowing atraumatic tooth extraction, a small full-thickness flap will be elevated without releasing incisions. A cortical lamina will be placed between the buccal bone plate and the elevated flap to isolate the periosteum and stabilize the ridge contour. The flap will then be repositioned and sutured for non-submerged healing. Sutures will be removed after two weeks. Standard postoperative care will include 0.12% chlorhexidine mouth rinses and analgesics as needed. |
| Control Group - Spontaneous Healing | Active comparator | Procedure: Natural Healing (Control)After tooth extraction, the site will be allowed to heal naturally without the placement of cortical lamina or any grafting material. The flap will be repositioned and sutured for non-submerged healing. Postoperative care will follow the same protocol as the test group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of a tooth indicated for extraction (maxillary incisors, canines, or premolars in either jaw).
- Age ≥ 21 years.
- Good general health with no contraindications for oral surgery.
- Non-pregnant individuals.
- Willingness to participate and sign written informed consent.
Key exclusion criteria (5 listed)
- Uncontrolled systemic disease (e.g., diabetes mellitus, hypertension).
- History of chemotherapy or radiotherapy.
- Current smokers of more than 10 cigarettes per day.
- Sites previously treated with regenerative or augmentation procedures.
- Poor oral hygiene or active periodontal infection.
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 |
|---|---|---|
| Cortical Lamina TechniqueSurgical placement of a cortical lamina between the buccal bone plate and elevated mucoperiosteal flap immediately after tooth extraction. The lamina serves as a barrier to stabilize the alveolar contour and promote bone preservation. The flap is sutured for non-submerged healing, and postoperative care includes chlorhexidine rinses and analgesics as needed. | Procedure or surgery | Test Group - Cortical Lamina Placement |
| Natural Healing (Control)After tooth extraction, the site will heal naturally without placement of cortical lamina or any grafting material. The flap is repositioned and sutured for non-submerged healing. Postoperative care is identical to the test group. | Procedure or surgery | Control Group - Spontaneous Healing |
Primary outcome
Change in Alveolar Ridge Width and Height
Time frame: Baseline (immediately post-extraction) to 6 months after extraction
Linear dimensional changes in the alveolar ridge (horizontal width and vertical height) will be evaluated using cone-beam computed tomography (CBCT) images taken immediately after tooth extraction (baseline) and six months post-surgery. Measurements will be made at standardized reference points on cross-sectional CBCT slices to quantify resorption or preservation of bone.
1 secondary outcome
Volumetric Change of the Alveolar Ridge
Time frame: Baseline to 6 months post-extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 30623987Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
- Results publication: PubMed 26020735Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2.
- Results publication: PubMed 10412845Richardson CR, Mellonig JT, Brunsvold MA, McDonnell HT, Cochran DL. Clinical evaluation of Bio-Oss: a bovine-derived xenograft for the treatment of periodontal osseous defects in humans. J Clin Periodontol. 1999 Jul;26(7):421-8. doi: 10.1034/j.1600-051x.1999.260702.x.
- Results publication: PubMed 29333325Lee JH, Yi GS, Lee JW, Kim DJ. Physicochemical characterization of porcine bone-derived grafting material and comparison with bovine xenografts for dental applications. J Periodontal Implant Sci. 2017 Dec;47(6):388-401. doi: 10.5051/jpis.2017.47.6.388. Epub 2017 Dec 31.
- Results publication: PubMed 1311759Klinge B, Alberius P, Isaksson S, Jonsson J. Osseous response to implanted natural bone mineral and synthetic hydroxylapatite ceramic in the repair of experimental skull bone defects. J Oral Maxillofac Surg. 1992 Mar;50(3):241-9. doi: 10.1016/0278-2391(92)90320-y.
- Results publication: PubMed 29303859Al Qabbani A, Al Kawas S, A Razak NH, Al Bayatti SW, Enezei HH, Samsudin AR, Sheikh Ab Hamid S. Three-Dimensional Radiological Assessment of Alveolar Bone Volume Preservation Using Bovine Bone Xenograft. J Craniofac Surg. 2018 Mar;29(2):e203-e209. doi: 10.1097/SCS.0000000000004263.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is conducted at a single clinical center with a limited sample size, and the data contain identifiable clinical imaging and patient information. Aggregated results and summary analyses will be made available through scientific publications and conference presentations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cortical Lamina Technique in people with Tooth Extraction and Periapical Infections, run by ARDEC Academy at 1 site in Cuba.
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 5 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: finished, as of the sponsor's last update on 19 Nov 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 Cuba. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alveolar Ridge Width and Height (time frame: Baseline (immediately post-extraction) to 6 months after extraction). 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 NCT07231874, which also lists 6 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 Nov 2025.