ProsthesesNCT05952765
Pink Esthetic Score Around Immediate Implants Using PDDM as Jumping Gap Filling Material.
A study testing Immediate implant in people with Prostheses and Endosseous Dental Implant Failure, run by Cairo University at 1 site in Egypt.
Trial summary
Will there be a difference in Pink Esthetic score and soft tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix compared with xenograft? Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostheses, Endosseous Dental Implant Failure
- What is being tested?
- Immediate implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2023to Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients above 18 years of age; with non-restorable teeth requiring replacement with immediate implants in the maxillary esthetic zone.
- Absence of active infection at the surgical site.
- Adequate primary stability following immediate implant placement.
- Intact socket walls following the extraction.
- Class I dental socket based on a preoperative CBCT scan
- Buccal plate thickness more than 1 mm and thick biotype.
- Compliant patients who will sign an informed consent and agree to the follow up period.
Who cannot join
- Poor oral hygiene or the lack of regular maintenance.
- Individuals with compromised immune system or debilitating systemic disease.
- The presence of parafunctional habits (bruxism or clenching).
- External root resorption.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine- Cairo University
Cairo, Cairo Governorate, 35855
Manal Hosny Mostafa, Professor, (+202) 23642938, manal.hosny@dentistry.cu.edu.eg
Mohamed Atef Bassiouny, lecturer, (+20)1224302609, Matef@hotmail.com
About this study
Official title: Evaluation of Pink Esthetic Score and Soft Tissue Changes Following Immediate Implants Using Partially Demineralized Dentin Matrix as Jumping Gap Filling Material Versus Xenograft. A Randomized Clinical Trial.
Will there be a difference in Pink Esthetic score and soft tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix compared with xenograft?
Read the detailed description
This study aims to evaluate the soft tissue changes as well as hard tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix in comparison to xenograft.
Because xenogeneic bone is so readily available in substantial quantities, it has been the subject of notable research. However, because they contain organic material from a foreign species, xenogeneic bones are inherently very antigenic.
According to experimental results, PDDM encourages bone regeneration in a manner like autogenous bone. Both cortical bone and autogenous tooth grafts share similar physical and chemical characteristics, including optimal biodegradability, not requiring a separate surgery to harvest the graft and space maintenance capabilities. PDDM is a valuable comparator to autogenous bone in ARP and around dental implants in guided bone regeneration procedures
- Conditions
- Prostheses, Endosseous Dental Implant Failure
- Being tested
- Immediate implant
- Keywords
- alveolar bone, immediate implant, soft tissue changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implantProcedure or surgery
- Local anesthesia Septanest special® will be administered prior to the procedure.
- Teeth extraction will be initiated by intrasulcular incision via 15 C blade without flap elevation.
- The tooth to be extracted will be luxated atraumatically using periotomes and thin straight elevator and delivered using forceps.
- The socket will be inspected for integrity, using a UNC graduated periodontal probe. grafting material either experimental or control will be used to graft jumping gap.
| Study group | Role | What they receive |
|---|---|---|
| Partially demineralized dentin matrix graft | Experimental | * A high-speed fine finishing stone and saline irrigation will be used to clean extracted teeth from periodontal ligaments, soft tissue attachments, caries, and restorations if present.
* Teeth particles will be partially demineralized using nitric acid 2% for fifteen minutes.
* Finally, the prepared partially demineralized dentin matrix graft granules will be washed twice with distilled water and phosphate buffered saline
* Immediate implant of appropriate dimensions will be placed and the previously prepared partially demineralized dentin matrix graft will be used to graft the jumping gap.
* Customized healing abutment will be used.
* In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months. Receives: Procedure: Immediate implant |
| xenograft | Active comparator | * After tooth extraction, thorough curettage will be performed.
* Immediate implant of appropriate dimensions will be placed, and the jumping gap will be grafted with xenograft "Cerabone" .
* Customized healing abutment will be used.
* In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months. Receives: Procedure: Immediate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink esthetic score
a fourteen point scale to evaluate pink esthetics. The pink esthetic score (PES) estimates the esthetic results of soft tissue surrounding the implant with regarding 7 points : mesial, distal papilla, soft tissue margin, soft tissue contour, alveolar process, colour, texture. the score of zero will be lowest and two will be the highest for each of the seven points with zero being the lowest and 14 being the highest.
Measured: twelve months after final restoration
Secondary outcomes (3)
Vertical and horizontal radiographic changes in bone dimensions
cone beam CT will be used to detect vertical and horizontal changes
Measured: immediate post operative and twelve months after final restoration
Midfacial mucosal alteration
rubber base impressions taken before the surgical procedure and 12 months after implant restoration. Then, casts were poured with type IV die stone and optically scanned. The obtained models were compared by digital superimposition in a matching software to measure the vertical alterations of the buccal peri-implant soft tissue.
Measured: preoperative and twelve months after final restoration
Patient satisfaction
a twelve point questionnaire to evaluate patient satisfaction
Measured: one year after final restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProsthesesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihad Ibrahim, Cairo University
- Investigators
- Manal Hosny Mostafa, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952765
- Sponsor's protocol ID
- 7691
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: baseline data and follow up measurements will be shared while keeping patients' identity protected.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pink Esthetic Score and Soft Tissue Changes Following Immediate Implants Using Partially Demineralized Dentin Matrix as Jumping Gap Filling Material Versus Xenograft. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05952765
- Acronym / sponsor ID
- 7691
- Conditions
- Prostheses, Endosseous Dental Implant Failure
- Keywords
- alveolar bone, immediate implant, soft tissue changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Jul 2023 (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.
Will there be a difference in Pink Esthetic score and soft tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix compared with xenograft?
Detailed description
This study aims to evaluate the soft tissue changes as well as hard tissue changes around immediate implants in maxillary esthetic zone following grafting the jumping gap with partially demineralized dentin matrix in comparison to xenograft.
Because xenogeneic bone is so readily available in substantial quantities, it has been the subject of notable research. However, because they contain organic material from a foreign species, xenogeneic bones are inherently very antigenic.
According to experimental results, PDDM encourages bone regeneration in a manner like autogenous bone. Both cortical bone and autogenous tooth grafts share similar physical and chemical characteristics, including optimal biodegradability, not requiring a separate surgery to harvest the graft and space maintenance capabilities. PDDM is a valuable comparator to autogenous bone in ARP and around dental implants in guided bone regeneration procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially demineralized dentin matrix graft | Experimental | Procedure: Immediate implant* A high-speed fine finishing stone and saline irrigation will be used to clean extracted teeth from periodontal ligaments, soft tissue attachments, caries, and restorations if present. * Teeth particles will be partially demineralized using nitric acid 2% for fifteen minutes. * Finally, the prepared partially demineralized dentin matrix graft granules will be washed twice with distilled water and phosphate buffered saline * Immediate implant of appropriate dimensions will be placed and the previously prepared partially demineralized dentin matrix graft will be used to graft the jumping gap. * Customized healing abutment will be used. * In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months. |
| xenograft | Active comparator | Procedure: Immediate implant* After tooth extraction, thorough curettage will be performed. * Immediate implant of appropriate dimensions will be placed, and the jumping gap will be grafted with xenograft "Cerabone" . * Customized healing abutment will be used. * In Osseo integrated implants temporary abutment will be removed and impressions for final restoration will be performed after 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients above 18 years of age; with non-restorable teeth requiring replacement with immediate implants in the maxillary esthetic zone.
- Absence of active infection at the surgical site.
- Adequate primary stability following immediate implant placement.
- Intact socket walls following the extraction.
- Class I dental socket based on a preoperative CBCT scan
Key exclusion criteria (4 listed)
- Poor oral hygiene or the lack of regular maintenance.
- Individuals with compromised immune system or debilitating systemic disease.
- The presence of parafunctional habits (bruxism or clenching).
- External root resorption.
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 |
|---|---|---|
| Immediate implant* Local anesthesia Septanest special® will be administered prior to the procedure. * Teeth extraction will be initiated by intrasulcular incision via 15 C blade without flap elevation. * The tooth to be extracted will be luxated atraumatically using periotomes and thin straight elevator and delivered using forceps. * The socket will be inspected for integrity, using a UNC graduated periodontal probe. grafting material either experimental or control will be used to graft jumping gap. | Procedure or surgery | Partially demineralized dentin matrix graft, xenograft |
Primary outcome
Pink esthetic score
Time frame: twelve months after final restoration
a fourteen point scale to evaluate pink esthetics. The pink esthetic score (PES) estimates the esthetic results of soft tissue surrounding the implant with regarding 7 points : mesial, distal papilla, soft tissue margin, soft tissue contour, alveolar process, colour, texture. the score of zero will be lowest and two will be the highest for each of the seven points with zero being the lowest and 14 being the highest.
3 secondary outcomes
Vertical and horizontal radiographic changes in bone dimensions
Time frame: immediate post operative and twelve months after final restoration
Midfacial mucosal alteration
Time frame: preoperative and twelve months after final restoration
Patient satisfaction
Time frame: one year after final restoration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: Yes. baseline data and follow up measurements will be shared while keeping patients' identity protected.
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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.
Manal Hosny Mostafa, Professor 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 Immediate implant in people with Prostheses and Endosseous Dental Implant Failure, 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 7 inclusion and 4 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 19 Jul 2023. 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?
Contact Mihad Ibrahim, M.Sc ((+20)1008551124, mihad.ibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink esthetic score (time frame: twelve months after final restoration). 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 19 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.