To Assess Bucco-lingual Dimension of the Ridge While Using Pontic Shield Technique as a Treatment Modality for Ridge PreservationNCT04566913
The Use Of Pontic Shield Technique For Alveolar Ridge Preservation . A Case Series
A study testing Pontic Shield Technique in people with To Assess Bucco-lingual Dimension of the Ridge While Using Pontic Shield Technique as a Treatment Modality for Ridge Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
To assess bucco-lingual dimension of the ridge while using pontic shield technique as a treatment modality for ridge preservation Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- To Assess Bucco-lingual Dimension of the Ridge While Using Pontic Shield Technique as a Treatment Modality for Ridge Preservation
- What is being tested?
- Pontic Shield Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 May 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
1-Inclusion Criteria:
1a- non-restorable teeth in the anterior esthetic zone
1b-Teeth not indicated for immediate implant placement for reasons such as acute periapical infection, insufficient buccolingual width, poor economical status
1c- Full mouth plaque score (FMPS )<25% at baseline
1d- Full mouth bleeding score (FMBS )<25% at baseline
1e -Systemically healthy
2-Exclusion Criteria:
2a- Fenestration or dehiscence in buccal plate 2b- Periodontally compromised tooth 2c- Mobility of the tooth or remaining root 2d- Smokers 2e- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical And Radiographic Evaluation Of The Use Of Pontic Shield Technique For Alveolar Ridge Preservation In The Esthetic Region . A Case Series
To assess bucco-lingual dimension of the ridge while using pontic shield technique as a treatment modality for ridge preservation
Read the detailed description
- Patients with non-restorable teeth in the esthetic area will be recruited from Faculty of Dentistry in Cairo University A pre-operative cone beam computed tomography ( CBCT ) will be taken to examine the non-restorable tooth , measure bucco-lingual width and exclude any fenestration or dehiscence in the labial bone plate
A non-surgical phase one therapy will be done for the patient as a preparatory phase
Proper oral hygiene measures and chlorohexidene mouthwash will be prescribed after the the first
Reassessment of the case to assure absence of any signs of inflammation and prescence of normal tissues before the surgical procedure
- The area will be anaesthetized using infiltration technique in labial site with 1.5ml of anaesthetic solution and palatal site with 0.3 ml of anaesthetic solution
- Decoronation of the tooth , if the crown is available, will be done to obtain a concave mesio-distal root
- A long shank root resection bur will be used to section the root mesiodistally as far apical as possible , in order to obtain the buccal half attached to the labial bone plate and together the apical and the palatal half will be attached to the palatal bone
- Periotome will be used to distort the periodontal ligaments between the palatal half of the root and palatal alveolar socket wall
- Together the apical and the palatal portions of the root will be delivered , using micro forceps
- Bone curettage will be done in the presence of peraipical infection
- Explorer will be used to exclude mobility of the buccal portion of the root
- The thickness of the buccal portion will be reduced to 2mm
- A large round bur will be used to reduce the height of the buccal portion in a mesiodistal direction.
- A bone grafting material will be placed in the remaining socket
- Being tested
- Pontic Shield Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pontic Shield TechniqueProcedure or surgery
- Together the apical and the palatal portions of the root in the esthetic region will be delivered and the buccal part is left for assessment of stability of bucco-palatal dimension of alveolar ridge
| Study group | Role | What they receive |
|---|---|---|
| Patients recruited from Cairo University | Experimental | After Cone beam CT assessment , The patient is assigned for nonsurgical periodontal phase then an impression is taken for stent formation to facilitate tissue thickness measurement .
> After 2 weeks , the patient is assigned for surgical phase to extract the palatal and apical aspect of the tooth and leave the buccal portion .
Socket preservation is attempted in the socket , using 'genbioss ' bone graft. Modified free gingival graft is done on the pontic site to cover the buccal root shield and the bone graft .
Post operative instructions include :
1. Analgesics (Prufen 400 mg ) three times for three days
2. Antibiotic (Augmentin 1gm ) twice daily for one week The patient will be assured to contact the operator of any unexpected complications occured . Receives: Procedure: Pontic Shield Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bucco-lingual ridge dimension
To assess the stability of the ridge after surgical procedure using bone calliper and CBCT via subtractive method technique
Measured: 6 months
Secondary outcomes (2)
Labial bone thickness
To assess the stability of labial plate after surgical procedure using CBCT via subtractive method technique
Measured: 6 months
Gingival thickness
assess the the thickness of labial tissue using endodontic spreader to identify a numerical value
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess Bucco-lingual Dimension of the Ridge While Using Pontic Shield Technique as a Treatment Modality for Ridge 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
- Model description
- Case Series study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mohamed Salah ELdin Thabet, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566913
- Sponsor's protocol ID
- 101292
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The exact procedure and results of all outcome after finishing the study
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Evaluation Of The Use Of Pontic Shield Technique For Alveolar Ridge Preservation In The Esthetic Region . A Case Series
- ClinicalTrials.gov ID
- NCT04566913
- Acronym / sponsor ID
- 101292
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Sep 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.
To assess bucco-lingual dimension of the ridge while using pontic shield technique as a treatment modality for ridge preservation
Detailed description
- Patients with non-restorable teeth in the esthetic area will be recruited from Faculty of Dentistry in Cairo University A pre-operative cone beam computed tomography ( CBCT ) will be taken to examine the non-restorable tooth , measure bucco-lingual width and exclude any fenestration or dehiscence in the labial bone plate
A non-surgical phase one therapy will be done for the patient as a preparatory phase
Proper oral hygiene measures and chlorohexidene mouthwash will be prescribed after the the first
Reassessment of the case to assure absence of any signs of inflammation and prescence of normal tissues before the surgical procedure
- The area will be anaesthetized using infiltration technique in labial site with 1.5ml of anaesthetic solution and palatal site with 0.3 ml of anaesthetic solution
- Decoronation of the tooth , if the crown is available, will be done to obtain a concave mesio-distal root
- A long shank root resection bur will be used to section the root mesiodistally as far apical as possible , in order to obtain the buccal half attached to the labial bone plate and together the apical and the palatal half will be attached to the palatal bone
- Periotome will be used to distort the periodontal ligaments between the palatal half of the root and palatal alveolar socket wall
- Together the apical and the palatal portions of the root will be delivered , using micro forceps
- Bone curettage will be done in the presence of peraipical infection
- Explorer will be used to exclude mobility of the buccal portion of the root
- The thickness of the buccal portion will be reduced to 2mm
- A large round bur will be used to reduce the height of the buccal portion in a mesiodistal direction.
- A bone grafting material will be placed in the remaining socket
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Series study
| Arm | Type | Receives |
|---|---|---|
| Patients recruited from Cairo University | Experimental | Procedure: Pontic Shield TechniqueAfter Cone beam CT assessment , The patient is assigned for nonsurgical periodontal phase then an impression is taken for stent formation to facilitate tissue thickness measurement . > After 2 weeks , the patient is assigned for surgical phase to extract the palatal and apical aspect of the tooth and leave the buccal portion . Socket preservation is attempted in the socket , using 'genbioss ' bone graft. Modified free gingival graft is done on the pontic site to cover the buccal root shield and the bone graft . Post operative instructions include : 1. Analgesics (Prufen 400 mg ) three times for three days 2. Antibiotic (Augmentin 1gm ) twice daily for one week The patient will be assured to contact the operator of any unexpected complications occured . |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Pontic Shield Technique• Together the apical and the palatal portions of the root in the esthetic region will be delivered and the buccal part is left for assessment of stability of bucco-palatal dimension of alveolar ridge | Procedure or surgery | Patients recruited from Cairo University |
Primary outcome
Bucco-lingual ridge dimension
Time frame: 6 months
To assess the stability of the ridge after surgical procedure using bone calliper and CBCT via subtractive method technique
2 secondary outcomes
Labial bone thickness
Time frame: 6 months
Gingival thickness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: Undecided. The exact procedure and results of all outcome after finishing the study
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 Pontic Shield Technique in people with To Assess Bucco-lingual Dimension of the Ridge While Using Pontic Shield Technique as a Treatment Modality for Ridge 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?
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 28 Sep 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 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?
Results are not available in the source record.
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?
Bucco-lingual ridge dimension (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 28 Sep 2020.