Socket PreservationNCT05255341
Clinical and Radiographic of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
A study testing roll pedicle connective tissue graft with bovine bone in people with Socket Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Read more about this study
- Who is it for?
- Ages 27 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- roll pedicle connective tissue graft with bovine bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jul 2019to 16 Sep 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 27 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- hopeless teeth that need tooth or root extraction in the maxillary esthetic zone.
- Alveolar socket Grade I and II.
- Normal platelet counts according to complete blood count (CBC) test done in the screening stage.
Who cannot join
- Acute infection at the extraction site
- Smokers ˃ 10 cigarettes / day.
- Medications that may interfere with wound healing
- History of treatment with bisphosphonates.
- History of allergic reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Therefore, socket preservation became an indispensable procedure as well as fundamental to prevent bone loss following tooth extraction. Preservation, by the name, is the maintenance of the socket, which is essentially the height and width of the gap that is left after the tooth is removed. It is done by placing a graft material or scaffold immediately into the socket of an extracted tooth to presto preserve bone height, width and density
Read the detailed description
Investigator evaluate the clinical and radio graphic effect of roll pedicle connective tissue graft as a barrier membrane together with bovine bone in alveolar ridge preservation in extraction sockets.
- Conditions
- Socket Preservation
- Being tested
- roll pedicle connective tissue graft with bovine bone
- Keywords
- socket preservation, vascularized interpositional connective tissue graft, alveolar ridge preservation techniques, bovine bone graft, roll pedicle graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roll pedicle connective tissue graft with bovine boneProcedure or surgery
Also called vascularized interpositional connective tissue graft
rotated pedicle connective tissue graft together with bovine bone applied for socket preservation after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| roll pedicle connective tissue graft with bovine bone | Experimental | 1. sulcular incisions were performed on the buccal and lingual aspects of the teeth to be extracted
2. Atraumatic extraction was made by periotome.
3. After tooth extraction the soft tissue was reflected at least 4 mm beyond the alveolar crest margin and the socket was filled with bovine derived xenograft and covered with roll pedicle connective tissue graft as a barrier membrane.
4. This pedicle is rolled under the buccal mucosa.The palatal connective tissue pedicle graft was outlined by full thickness incision along the oblique incision line, and parallel incision given from the mesial line angle of target place and reflected coronally up to the crest of the ridge defect. then a partial thickness incision was made extending beyond the line angles of adjacent incisors and mucogingival junction, leaving the periosteum on the bone.
5. the pedicle graft was rolled from the apical end and secured with interrupted sutures to the labial flap. Receives: Procedure: roll pedicle connective tissue graft with bovine bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
width of alveolar bone
Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted.
The buccopalatal width of the alveolar ridge will be measured at the two assigned points using bone caliper at baseline and 6 months post extraction
Measured: changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months
Secondary outcomes (2)
gingival thickness
Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted.
The gingival thickness will be evaluated by William's graduated periodontal probe inserted horizontally perpendicular to the alveolar bone at the two assigned holes labially/buccally at baseline and 6 Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted.
The gingival thickness will be evaluated by William's graduated periodontal probe inserted horizontally perpendicular to the alveolar bone at the two assigned holes labially/buccally at baseline and 6 months post extraction.
months post extraction.
Measured: changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)
height of the alveolar crest
Crestal bone height was measured to determine the amount of bone at gain using digora soft ware
Measured: changes in height of alveolar crest were measured at baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start16 Jul 2019
- Primary completion1 Mar 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Magdy Salem Amen Eladly, Cairo University
- Investigators
- noha magdy salem amin, Principal investigator, cairo university- faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255341
- Sponsor's protocol ID
- roll pedicle graft
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 11 Mar 2022
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
- ClinicalTrials.gov ID
- NCT05255341
- Acronym / sponsor ID
- roll pedicle graft
- Conditions
- Socket Preservation
- Keywords
- socket preservation, vascularized interpositional connective tissue graft, alveolar ridge preservation techniques, bovine bone graft, roll pedicle graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 24 Feb 2022 (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.
After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Therefore, socket preservation became an indispensable procedure as well as fundamental to prevent bone loss following tooth extraction. Preservation, by the name, is the maintenance of the socket, which is essentially the height and width of the gap that is left after the tooth is removed. It is done by placing a graft material or scaffold immediately into the socket of an extracted tooth to presto preserve bone height, width and density
Detailed description
Investigator evaluate the clinical and radio graphic effect of roll pedicle connective tissue graft as a barrier membrane together with bovine bone in alveolar ridge preservation in extraction sockets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| roll pedicle connective tissue graft with bovine bone | Experimental | Procedure: roll pedicle connective tissue graft with bovine bone1. sulcular incisions were performed on the buccal and lingual aspects of the teeth to be extracted 2. Atraumatic extraction was made by periotome. 3. After tooth extraction the soft tissue was reflected at least 4 mm beyond the alveolar crest margin and the socket was filled with bovine derived xenograft and covered with roll pedicle connective tissue graft as a barrier membrane. 4. This pedicle is rolled under the buccal mucosa.The palatal connective tissue pedicle graft was outlined by full thickness incision along the oblique incision line, and parallel incision given from the mesial line angle of target place and reflected coronally up to the crest of the ridge defect. then a partial thickness incision was made extending beyond the line angles of adjacent incisors and mucogingival junction, leaving the periosteum on the bone. 5. the pedicle graft was rolled from the apical end and secured with interrupted sutures to the labial flap. |
Who may qualify
- Ages
- 27 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • patients with healthy systemic condition.
Key exclusion criteria (5 listed)
- Acute infection at the extraction site
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 |
|---|---|---|
| roll pedicle connective tissue graft with bovine boneAlso: vascularized interpositional connective tissue graftrotated pedicle connective tissue graft together with bovine bone applied for socket preservation after tooth extraction | Procedure or surgery | roll pedicle connective tissue graft with bovine bone |
Primary outcome
width of alveolar bone
Time frame: changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months
Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted. The buccopalatal width of the alveolar ridge will be measured at the two assigned points using bone caliper at baseline and 6 months post extraction
2 secondary outcomes
gingival thickness
Time frame: changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)
height of the alveolar crest
Time frame: changes in height of alveolar crest were measured at baseline, 3 months and 6 months
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 11 Mar 2022.
Related trials for Socket Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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.
noha magdy salem amin principal investigator
cairo university- faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing roll pedicle connective tissue graft with bovine bone in people with Socket Preservation, run by Cairo University at 1 site in Egypt.
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 11 Mar 2022. 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 Egypt. 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?
width of alveolar bone (time frame: changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months). 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 11 Mar 2022.