Evaluation of Papilla Index Around Immediate Mandibular Molar Implants Using Customized Healing Abutment Versus Submerged Healing
Clinical Evaluation of Papilla Index Around Immediate Implant Placement in Mandibular Molars Using Chairside Customized Healing Abutment Versus Submerged Healing :A Randomized Controlled Clinical Trial
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
The original implant treatment protocol recommended that the implant should be placed in a fully healed site and covered with mucosa after placement to ensure osseointegration. The reason was to protect the implant site from bacterial contamination and to avoid loading of the implant. After that, a second stage surgical procedure had to be performed to expose the implant to connect the abutment. However, it was shown that a one stage or non-submerged (NS) approach can lead to successful and predictable outcomes. Customized healing abutments can be used in the non-submerged protocol, protecting and containing the bone substitute during healing, preserving the alveolar contour, preventing food impaction, and eliminating the need for a second stage surgery and. By means of this technique, critical and subcritical contours can be projected speeding up the peri-implant soft tissue conditioning phase in order to achieve final natural-like restorations. This randomized controlled trial will compare the clinical and radiographic hard and soft tissue changes using chairside customized healing abutment versus submerged healing following immediate implant placement in mandibular molars through measuring the horizontal ridge changes by CBCT , the crestal bone loss by a standardized digital x-ray and the soft tissue changes by the pink esthetic score (PES).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 26, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJune 26, 2020
June 1, 2020
2.7 years
June 19, 2020
June 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Papilla Index
JEMT Index (mm.)
1 year follow up
Secondary Outcomes (4)
Hard tissue horizontal ridge changes (bucco lingual)
1 year follow up
Crestal bone loss
1 year follow up
Soft tissue profile
1 year follow up
Satisfaction index
1 year follow up
Study Arms (2)
Immediate molar implant with customized healing abutment
EXPERIMENTALPatients will receive an immediate mandibular molar implant with customized healing abutment
Immediate molar implant with submerged healing
ACTIVE COMPARATORPatients will receive an immediate mandibular molar implant with submerged healing
Interventions
Patients will receive an immediate implant with customized healing abutment 1. Atraumatic extraction without flap elevation using periotomes and elevators then sectioning of the roots will be performed to preserve the interseptal bone. 2. The drilling will be performed starting from the pilot drill in the interseptal bone to the twisting drills according to the manufacturer's instructions to the selected implant size. The implant is to be placed immediately then the insertion torque will be measured using a torque wrench. In order to place the customized healing abutment, the insertion torque should be more than 25 ncm. 3. The gap distance will be filled by xenograft, a plastic abutment will be screwed in place then a flowable composie resin will be applied around into small amounts and cured to take the soft tissue contour then finishing and polishing of the customized healing abutment will be done.
Eligibility Criteria
You may qualify if:
- Patients age between 20 and 70 years old.
- Patients with non-restorable mandibular molars
- Medically free.
- Integrity of the extraction socket wall
- Patients who are able to sign an informed consent form.
- Cooperative, motivated and hygiene conscious Patients.
- Patients who are able to come for the follow up appointments.
You may not qualify if:
- Patients with compromised general health conditions that would impair bone healing including: Past or present history of bone irradiation Patients taking bisphosphonates
- Teeth with acute periapical pathosis
- Heavy Smokers
- Parafunctional habits
- Pregnant females
- Drug abusers
- Uncontrolled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (1)
Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.
PMID: 31797548BACKGROUND
Study Officials
- STUDY CHAIR
Omnia Aboul Dahab, Phd
Cairo University
- STUDY CHAIR
Hani El-Nahas, Phd
Cairo University
- STUDY CHAIR
Omnia K. Tawfik, Phd
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- single blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching assistant
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 26, 2020
Study Start
September 1, 2020
Primary Completion
June 1, 2023
Study Completion
October 1, 2023
Last Updated
June 26, 2020
Record last verified: 2020-06