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Pink Esthetic Score Around Immediate Implants Using PDDM as Jumping Gap Filling Material.

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05952765
Enrollment
24
Registered
2023-07-19
Start date
2023-08-31
Completion date
2025-06-30
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endosseous Dental Implant Failure, Prostheses

Keywords

alveolar bone, immediate implant, soft tissue changes

Brief 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?

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

Interventions

PROCEDUREImmediate 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive (PDDM), and which will receive xenograft will be taken according to the randomized numbers placed in opaque sealed envelopes. The number will be picked by the supervisor.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pink esthetic scoretwelve months after final restorationa 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.

Secondary

MeasureTime frameDescription
Vertical and horizontal radiographic changes in bone dimensionsimmediate post operative and twelve months after final restorationcone beam CT will be used to detect vertical and horizontal changes
Midfacial mucosal alterationpreoperative and twelve months after final restorationrubber 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.
Patient satisfactionone year after final restorationa twelve point questionnaire to evaluate patient satisfaction

Countries

Egypt

Contacts

Primary ContactMihad Ibrahim, M.Sc
mihad.ibrahim@dentistry.cu.edu.eg(+20)1008551124

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026