Alveolar Ridge CollapseNCT04482127
Volumetric Analysis of Alveolar Ridge Contour Using Sub-epithelial Connective Tissue Graft
A study testing SubEpithelial connective graft in people with Alveolar Ridge Collapse, run by Cairo University at 1 site in Egypt.
Trial summary
This study will monitor the effect of soft tissue augmentation using sub-epithelial connective tissue graft buccal to extraction sockets in anterior maxilla in thin dento-alveolar phenotype; and will evaluate whether it will enhance the alveolar ridge contour and improve the gingival phenotype following atraumatic… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Collapse
- What is being tested?
- SubEpithelial connective graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2020to 1 Dec 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults from the age of 18 - 40 years
- Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
- Intact gingival tissue with at least 2mm keratinized tissue
- Buccal bone thickness should be 1mm or less assessed by CBCT before extraction
- Periodontally healthy patients
- Patients accepts to provide informed consent
Who cannot join
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Presence of systemic disease that would affect wound healing.
- Presence of active infection with soft tissue communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-extraction Volumetric Analysis of Alveolar Ridge Contour Using Subepithelial Connective Tissue Graft in Esthetic Zone: A Randomized Controlled Clinical Trial
This study will monitor the effect of soft tissue augmentation using sub-epithelial connective tissue graft buccal to extraction sockets in anterior maxilla in thin dento-alveolar phenotype; and will evaluate whether it will enhance the alveolar ridge contour and improve the gingival phenotype following atraumatic extraction compared with no treatment at all in terms of Ridge contour Preservation for future esthetically acceptable fixed prothesis.
Read the detailed description
The aim of this study is to assess the alveolar ridge contour after soft tissue augmentation using sub-epithelial connective tissue graft buccal to fresh extraction sockets in patient with thin buccal bone, versus atraumatic extraction with no soft tissue augmentation.
Group A: Patients receiving atraumatic extraction with soft tissue augmentation by sub-epithelial connective tissue graft buccal to extraction sockets.
Group B: Patients receiving normal atraumatic extraction with no soft tissue augmentation
Clinical examination:
- Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions.
- Evaluation of the buccal bone thickness using CBCT as diagnostic aid. (After CBCT if the patient was excluded because of thick buccal bone, he/she will be referred for implant placement)
- Evaluation of gingival phenotype before extraction using visual technique via periodontal probe.
- After patient enrollment, full mouth scaling to be done first and home oral hygiene measures to be done by patient. At the day of the surgery, immediately before extraction, an impression will be taken using alginate material and wax molded stock tray for recording the original ridge contour as the baseline data. casts will be made with dental extra hard stone.
Surgical procedure:
After administration of local anesthesia, the tooth will be extracted without raising flaps, as atraumatic as possible without disturbing the papillary tissues. After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions.
Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested from palatal tissue by single line incision technique blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.
The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place.
Pouch II technique:
A SCTG with a minimum thickness of 1.5 mm will be harvested from the palate. Following extraction, a full-thickness envelope flap will be created between the facial bone plate and the overlying gingiva. The SCTG will be inserted into the prepared envelope and secured with resorbable suture material. The apico-coronal dimension of the SCTG will be standardized throughout all the cases.
Group B will receive atraumatic extraction with no soft tissue augmentation.
(All patients assigned to the study will be referred to receive Prosthesis after treatment.)
- Conditions
- Alveolar Ridge Collapse
- Being tested
- SubEpithelial connective graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SubEpithelial connective graftOther
Connective tissue graft harvested from hard palate, to be placed buccal to extraction sockets in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| SubEpithelial connective graft | Experimental | SCTG harvested from palatal tissue by single line incision technique, blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.
The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Receives: Other: SubEpithelial connective graft |
| Atraumatic extraction | No intervention | Extraction with Periotomes and Luxators keeping the buccal plate of bone intact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal soft tissue contour
Volumetric analysis using pre and post impressions and a digital software (V.Vanhoutte, et al. 2013) (Van Nimwegen, et al 2018). The soft tissue contours of the extraction sites will be assessed quantitatively. Impressions will be taken at 3 time-points, that is, before tooth extraction (baseline, T0) and 3 (T1), and 6 (T2) months after surgery. Plaster casts will be generated subsequently and digitised with a laser scanner. For the final analyses, CAD software is to be used to match the corresponding follow-up states (T1 to T2) with the baseline state (T0) and evaluate sections at defined positions with standardization of the apico-coronal dimension of SCTG.
Measured: 6 Months
Secondary outcomes (2)
Gingival Thickness
Gingival Thickness (GT) using Anesthetic Needle with a stopper (Paolantonio et al., 2002) will be measure at base line before extraction (T0), and during the follow up periods (T1 and T2)
Measured: 6 Months
Interdental Papilla height
height of papilla fill
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 posted22 Jul 2020
- Study start12 Mar 2020
- Primary completion13 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge CollapseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested from palatal tissue by single line incision technique (Hürzeler and Weng, 1999) blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft. Group B will receive atraumatic extraction with no soft tissue augmentation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal A Aziz, Cairo University
- Investigators
- Nourhan Gamal, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482127
- Sponsor's protocol ID
- PER 632
- Status last verified
- Aug 2024
- First submitted
- 27 Apr 2020
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-extraction Volumetric Analysis of Alveolar Ridge Contour Using Subepithelial Connective Tissue Graft in Esthetic Zone: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04482127
- Acronym / sponsor ID
- PER 632
- Conditions
- Alveolar Ridge Collapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 22 Jul 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.
This study will monitor the effect of soft tissue augmentation using sub-epithelial connective tissue graft buccal to extraction sockets in anterior maxilla in thin dento-alveolar phenotype; and will evaluate whether it will enhance the alveolar ridge contour and improve the gingival phenotype following atraumatic extraction compared with no treatment at all in terms of Ridge contour Preservation for future esthetically acceptable fixed prothesis.
Detailed description
The aim of this study is to assess the alveolar ridge contour after soft tissue augmentation using sub-epithelial connective tissue graft buccal to fresh extraction sockets in patient with thin buccal bone, versus atraumatic extraction with no soft tissue augmentation.
Group A: Patients receiving atraumatic extraction with soft tissue augmentation by sub-epithelial connective tissue graft buccal to extraction sockets.
Group B: Patients receiving normal atraumatic extraction with no soft tissue augmentation
Clinical examination:
- Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions.
- Evaluation of the buccal bone thickness using CBCT as diagnostic aid. (After CBCT if the patient was excluded because of thick buccal bone, he/she will be referred for implant placement)
- Evaluation of gingival phenotype before extraction using visual technique via periodontal probe.
- After patient enrollment, full mouth scaling to be done first and home oral hygiene measures to be done by patient. At the day of the surgery, immediately before extraction, an impression will be taken using alginate material and wax molded stock tray for recording the original ridge contour as the baseline data. casts will be made with dental extra hard stone.
Surgical procedure:
After administration of local anesthesia, the tooth will be extracted without raising flaps, as atraumatic as possible without disturbing the papillary tissues. After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions.
Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested from palatal tissue by single line incision technique blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.
The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place.
Pouch II technique:
A SCTG with a minimum thickness of 1.5 mm will be harvested from the palate. Following extraction, a full-thickness envelope flap will be created between the facial bone plate and the overlying gingiva. The SCTG will be inserted into the prepared envelope and secured with resorbable suture material. The apico-coronal dimension of the SCTG will be standardized throughout all the cases.
Group B will receive atraumatic extraction with no soft tissue augmentation.
(All patients assigned to the study will be referred to receive Prosthesis after treatment.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested from palatal tissue by single line incision technique (Hürzeler and Weng, 1999) blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft. Group B will receive atraumatic extraction with no soft tissue augmentation.
| Arm | Type | Receives |
|---|---|---|
| SubEpithelial connective graft | Experimental | Other: SubEpithelial connective graftSCTG harvested from palatal tissue by single line incision technique, blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft. The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. |
| Atraumatic extraction | No intervention | –Extraction with Periotomes and Luxators keeping the buccal plate of bone intact |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults from the age of 18 - 40 years
- Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
- Intact gingival tissue with at least 2mm keratinized tissue
- Buccal bone thickness should be 1mm or less assessed by CBCT before extraction
- Periodontally healthy patients
Key exclusion criteria (6 listed)
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Presence of systemic disease that would affect wound healing.
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 |
|---|---|---|
| SubEpithelial connective graftConnective tissue graft harvested from hard palate, to be placed buccal to extraction sockets in the intervention group | Other | SubEpithelial connective graft |
Primary outcome
Buccal soft tissue contour
Time frame: 6 Months
Volumetric analysis using pre and post impressions and a digital software (V.Vanhoutte, et al. 2013) (Van Nimwegen, et al 2018). The soft tissue contours of the extraction sites will be assessed quantitatively. Impressions will be taken at 3 time-points, that is, before tooth extraction (baseline, T0) and 3 (T1), and 6 (T2) months after surgery. Plaster casts will be generated subsequently and digitised with a laser scanner. For the final analyses, CAD software is to be used to match the corresponding follow-up states (T1 to T2) with the baseline state (T0) and evaluate sections at defined positions with standardization of the apico-coronal dimension of SCTG.
2 secondary outcomes
Gingival Thickness
Time frame: 6 Months
Interdental Papilla height
Time frame: 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 21 Aug 2024.
- Individual participant dataSharing planned: Undecided
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.
Nourhan Gamal principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SubEpithelial connective graft in people with Alveolar Ridge Collapse, 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 6 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: finished, as of the sponsor's last update on 21 Aug 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 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?
Buccal soft tissue contour (time frame: 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 21 Aug 2024.