Dental ImplantNCT05988281
Success of Implant Restorations After Immediate or Delayed Implant Placement With/Without Ridge Preservation
A study testing Type I Dental implant placement., Type II Dental implant placement. and Type III/IV dental implant placement. in people with Dental Implant, run by Hospital General Universitario Morales Meseguer.
Trial summary
The study aims to compare clinical, radiographic, patient-reported outcomes (PROMs) and cost analysis outcomes in type I, II and socket preserved sites (III/IV) implant placement at 1-year post-loading in all groups. Read more about this study
- Who is it for?
- Ages 23 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Type I Dental implant placement., Type II Dental implant placement. and Type III/IV dental implant placement.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 23 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥23 years old.
- Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for two thirds of the root not associated with acute periapical pathology.
- Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of >50% buccal bone loss, the participant will be withdrawn from the study.
- Patient in good general health as documented by self-assessment. v) Full mouth bleeding and plaque scores (FMBS <10% and FMPS <30%) recorded within the previous 8 weeks.
Who cannot join
- Uncontrolled or untreated periodontal disease. ii) History of local (head and neck) radiation therapy. iii) Presence of oral lesions in the area of the extraction (such as ulceration, malignancy).
- Severe bruxing or clenching habits. v) Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible).
- Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. AIDS).
- History of alcohol or drug abuse. viii) Smokers. ix) Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- Malocclusion, or collapse of the occlusal vertical dimension leading to dentoalveolar compensation which could interfere with ridge preservation dimensions and measurements.
- Lack of adjacent sound restored or unrestored teeth.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Success of Implant Supported Restorations After Immediate Implant Placement or Delayed Implant Placement With or Without Ridge Preservation
The study aims to compare clinical, radiographic, patient-reported outcomes (PROMs) and cost analysis outcomes in type I, II and socket preserved sites (III/IV) implant placement at 1-year post-loading in all groups.
Read the detailed description
This is a prospective, parallel-group, randomized study aiming to compare clinical, radiographic, PROMS and health-economic outcomes of type I, type II and type III/IV (in socket preserved areas) implant placement.
This study included three groups:
- Immediate implant placement + aputogenous connective tissue graft (CTG) (type I). ii. Early implant placement (type II, after 6-8 weeks). iii. Delayed/late placement in socket-preserved sites (type III/IV, after 3-6 months).
Up 75-90 adult, systemically healthy patients will be recruited mainly in the new patient and follow-up implant clinics which run every week at the Murcia University Dental Hospital Morales Meseguer. In addition, patients with unrestorable maxillary premolars, canines and incisors will be recruited from other relevant clinics within the same hospital, such as Periodontics, Endodontics/Dental Trauma Restorative Dentistry, Oral Surgery and Hypodontia outpatient clinics. Flyers advertising the study will also be placed in the Hospital and in the reception area to be visible.
After screening patients, the potentially eligible participants will be given the patient information sheet and they will be invited to attend the enrolment visit at Murcia University Dental Hospital Morales Meseguer . Before any study-related intervention is performed, informed consent will be obtained. During the enrolment visit, a detailed medical history will be taken and the periodontal parameters adjacent to the tooth to replace will be recorded. The GDP will be sent a letter to inform him/her about the enrolment of their patient in the study and about the need for any dental treatment (if needed).
Below is a summary of all study visits for each study group:
- For type-I placement: Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement. Visit 2: Extraction, CBCT post extraction and provision of immediate implant. Visit 3: Suture removal. Visit 4: Provision of second stage surgery after 12-14 weeks. Visit 5: Impressions for temporary restoration after 2 weeks. Visit 6: Provision of temporary restoration after 2-4 weeks. Visit 7: Impressions for final restoration after 3-6 months. Visit 8: Provision of final implant restoration. Visit 9: Final visit for data collection at 12 months post-loading and CBCT.
- For type-II placement: Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement. Visit 2: Extraction, CBCT post extraction. Visit 3: Suture removal after 1-2 weeks. Visit 4: Provision of type II placement after 6-8 weeks. Visit 5: Suture removal after 1-2 weeks. Visit 6: Provision of second stage surgery after 12-14 weeks. Visit 7: Impressions for temporary restoration after 2 weeks. Visit 8: Provision of temporary restoration after 2-4 weeks. Visit 9: Impressions for final restoration after 3-6 months. Visit 10: Provision of permanent implant restoration. Visit 11: Final visit for data collection at 12 months post-loading and CBCT.
- For socket-preserved sites with type-III/IV placement:
Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement.
Visit 2: Extraction, CBCT post extraction and provision of ARP. Visit 3: Suture removal after 1-2 weeks. Visit 4: Visit 5: Provision of type III/IV placement after 12-24weeks. Visit 5: Suture removal after 1-2 weeks. Visit 6: Provision of second stage surgery after 12-14 weeks. Visit 7: Impressions for temporary restoration after 2 weeks. Visit 8: Provision of temporary restoration after 2-4 weeks. Visit 9: Impressions for final restoration after 3-6 months. Visit 10: Provision of final implant restoration. Visit 11: Final visit for data collection at 12 months post-loading and CBCT.
- Conditions
- Dental Implant
- Being tested
- Type I Dental implant placement., Type II Dental implant placement., Type III/IV dental implant placement.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type I Dental implant placement.Procedure or surgery
Placement of dental implant.
Type II Dental implant placement.Procedure or surgery
Placement of dental implant.
Type III/IV dental implant placement.Procedure or surgery
Placement of dental implant.
| Study group | Role | What they receive |
|---|---|---|
| Type I dental implant placement. | Experimental | Type I dental implant placement (immediately after extraction) Receives: Procedure: Type I Dental implant placement. |
| Type II dental implant placement. | Experimental | Type II dental implant placement (6-8 weeks after extraction) Receives: Procedure: Type II Dental implant placement. |
| Type III/IV placement. | Experimental | Type III/IV placement in socket preserved sites after 3-6 months. Receives: Procedure: Type III/IV dental implant placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined success rate criteria.
This is the success criteria described by Ong et al. 2008, in combintation with predetermined scores for PES/WES as decribed in Garcia-Sanchez et al. 2021.
Measured: 12 months after delivery of implant restoration.
Secondary outcomes (25)
Pre-treatment outcome. Total Need for further bone augmentation.
Expressed as a percentage (%) of implants that required further ridge augmentation procedures during implant placement.
Measured: At implant placement.
Pre-treatment outcome. Alveolar ridge dimensions clinically.
- Width at mesial/mid/ distal site ii. Height (from the CEJ of neighbouring teeth) at mesial /mid / distal site (clinical) at post extraction, 2 months for typeII, 4 months for Type III/IV, at second stage for all groups. iii. Defect characterisation.
Measured: Immediately after dental extraction for type I, at month 2 for type II, at month 4 for type III/IV and at second stage surgery (10-12 weeks after implant placement) for all groups.
Pre-treatment outcome. Alveolar ridge dimensions radiographic:
- Width at mesial/mid/ distal site ii. Height (from a radiopaque stent) at mesial /mid / distal site. iii. Area at post extraction, at month 2 for type2, at month 4 for Type III/IV , at 12 months post loading for all groups.
Measured: Immediately after dental extraction for type I, at month 2 for type II, at month 4 for type III/IV and at 12 months post-loading for all groups.
Pre-treatment outcome. Periodontal phenotype
This to be descibed as per EFP/AAP workshop.
Measured: Before dental extraction.
Pre-treatment outcome. Keratinised attached gingivae before extraction.
Expressed in mm and measured with periodontal probe/photograph.
Measured: Before dental extraction.
Pre-treatment outcome. Thickness of buccal wall (radiographic) before extraction.
As measured in CBCT
Measured: Before dental extraction
Pre-treatment outcome. Soft tissue thickness buccally.
Either clinical or radiographic at 3mm from CEJ. Expressed in mm and measured with periodontal probe.
Measured: Before dental extraction.
Pre-treatment outcome. Soft tissue recession.
Cemento Enamel Junction/Stent as a reference point expressed in mm and measured with periodontal probe/photograph.
Measured: Before dental extraction
Pre-treatment outcome. Sounding of soft tissue vertical at proximal sites.
Expressed in mm and measured with periodontal probe.
Measured: Before dental extraction and at implant placement.
Implant-related outcome. Survival at 12 months post-loading.
Implants still in mouth regardless of condition
Measured: At 12-months post-loading.
Implant-related outcome. Feasibility of implant placement.
Expressed as percentages (%) of implants placed with satisfactory primary stability (> 30N/cm).
Measured: At implant placement.
Implant-related outcome. Final torque placement.
Expressed as n/cm
Measured: At implant placement.
Implant-related outcome. Need for further soft tissue augmentation (soft tissue contour deficiencies).
Expressed as percentages (%) of implants placed that requires additional soft tissue grafting.
Measured: At implant placement or second stage surgery (10-12 weeks after dental implant placement).
Implant-related outcomes. Total surgical hours.
Number of hours/minutes needed to complete specific surgical procedure.
Measured: Overall surgical time in that specific arm group.
Implant-related outcome. Papillary Fill Index
As per index agreed.
Measured: At 1 and 12 months post-loading.
Implant-related outcome. Proximal bone levels (radiographic)
Expressed as mm of bone loss (-) /gain (+).
Measured: At 1 and 12 months post-loading.
Implant-related outcome. Probing pocket depth around implants.
Expressed in mm after gentle probing (30-40 newtons).
Measured: At 1 and 12 months post-loading.
Implant-related outcome. Intra - surgical complications.
Expressed as percentage (%) of implants experiencing complications during implant placement.
Measured: At dental implant placement
Implant-related outcome. Post-surgical complications.
Percentage (%) of implants experiencing complications from the moment implant was placed until loading.
Measured: Period from implant placement to implant loading. Normally this period last between 10-12 weeks.
Implant-related outcome. Technical/ mechanical complications
Percentage (%) of implants experiencing aforementioned complications during at 1 at 12M post Loading.
Measured: At 1 and 12 months post-loading.
Implant-related outcome. Biologic complications.
Percentage (%) of implants experiencing aforementioned complications during at 1 at 12M post Loading.
Measured: At 1 and 12 months post-loading.
Implant-related outcome. Post-operative clinical measurements.
- Keratinised attached Mucosa around the implant at 12 months post loading ii.Soft tissue thickness buccally (12 months post loading -either clinical or radiographic at 3/ 5mm from implant shoulder ). iii. Recession. iv. Soft tissue vertical at proximal sites at 12 months post-loading. v. Changes in the external alveolar ridge contour/soft tissue (optical scan measurements). before extraction, before implant placement, and at 12 months post-loading vi. Buccal \& palatal plate dimensions (height and thickness) immediately after dental extraction.
Measured: Immediately after extraction and at 12 month post-loading
Implant-related outcome.Histomorphometry of new bone formation in type III/IV implant placement.
This assessed with Scanning Electron Microscope (SEM) and X-ray microtomography (XMT), to calculate the percentages of new bone within bone core samples.
Measured: At 3 months of healing at the dental implant group III/IV.
Patient-reported outcome. VAS pain score after surgery for each group.
Visual Analog Scale (VAS) divided in ten equal segments in which patient will rate pain from no pain (0) to the most severe pain that could be experienced (10).
Measured: 2 weeks after implant placement surgery.
Patient-reported outcome. Patient satisfaction with treatment outcome.
Questionnarie
Measured: At 12 months post-loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- 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
- Model description
- This is a prospective, parallel-group, randomized study. This study will include three groups: i. Immediate dental implant placement with autogenous connective tissue graft (type I). ii. Early dental implant placement (type II). iii. Delayed/late dental implant placement in socket-preserved sites (type III/IV).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Morales Meseguer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Garcia-Sanchez, Hospital General Universitario Morales Meseguer
- Investigators
- Guillermo Pardo Zamora, Dr., Study director, Universidad de Murcia. Associate Professor.Ruben Garcia-Sanchez, Dr., Principal investigator, Universidad de Murcia. Associate Professor.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988281
- Sponsor's protocol ID
- UM-RP001
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Guillermo Pardo Zamora (gparza@um.es). This data will become available once the study results are published. The data available will be all of the individual participant data collected during the trial, after deidentification. This data will be available 3 months after publication and ending 5 years following article publication. This data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The data will be shared to achieve the aims in the approved proposal. Proposals should be directed to Dr Guillermo Pardo Zamora (gparza@um.es). To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success of Implant Supported Restorations After Immediate Implant Placement or Delayed Implant Placement With or Without Ridge Preservation
- ClinicalTrials.gov ID
- NCT05988281
- Acronym / sponsor ID
- UM-RP001
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospital General Universitario Morales MeseguerUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Aug 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.
The study aims to compare clinical, radiographic, patient-reported outcomes (PROMs) and cost analysis outcomes in type I, II and socket preserved sites (III/IV) implant placement at 1-year post-loading in all groups.
Detailed description
This is a prospective, parallel-group, randomized study aiming to compare clinical, radiographic, PROMS and health-economic outcomes of type I, type II and type III/IV (in socket preserved areas) implant placement.
This study included three groups:
- Immediate implant placement + aputogenous connective tissue graft (CTG) (type I). ii. Early implant placement (type II, after 6-8 weeks). iii. Delayed/late placement in socket-preserved sites (type III/IV, after 3-6 months).
Up 75-90 adult, systemically healthy patients will be recruited mainly in the new patient and follow-up implant clinics which run every week at the Murcia University Dental Hospital Morales Meseguer. In addition, patients with unrestorable maxillary premolars, canines and incisors will be recruited from other relevant clinics within the same hospital, such as Periodontics, Endodontics/Dental Trauma Restorative Dentistry, Oral Surgery and Hypodontia outpatient clinics. Flyers advertising the study will also be placed in the Hospital and in the reception area to be visible.
After screening patients, the potentially eligible participants will be given the patient information sheet and they will be invited to attend the enrolment visit at Murcia University Dental Hospital Morales Meseguer . Before any study-related intervention is performed, informed consent will be obtained. During the enrolment visit, a detailed medical history will be taken and the periodontal parameters adjacent to the tooth to replace will be recorded. The GDP will be sent a letter to inform him/her about the enrolment of their patient in the study and about the need for any dental treatment (if needed).
Below is a summary of all study visits for each study group:
- For type-I placement: Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement. Visit 2: Extraction, CBCT post extraction and provision of immediate implant. Visit 3: Suture removal. Visit 4: Provision of second stage surgery after 12-14 weeks. Visit 5: Impressions for temporary restoration after 2 weeks. Visit 6: Provision of temporary restoration after 2-4 weeks. Visit 7: Impressions for final restoration after 3-6 months. Visit 8: Provision of final implant restoration. Visit 9: Final visit for data collection at 12 months post-loading and CBCT.
- For type-II placement: Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement. Visit 2: Extraction, CBCT post extraction. Visit 3: Suture removal after 1-2 weeks. Visit 4: Provision of type II placement after 6-8 weeks. Visit 5: Suture removal after 1-2 weeks. Visit 6: Provision of second stage surgery after 12-14 weeks. Visit 7: Impressions for temporary restoration after 2 weeks. Visit 8: Provision of temporary restoration after 2-4 weeks. Visit 9: Impressions for final restoration after 3-6 months. Visit 10: Provision of permanent implant restoration. Visit 11: Final visit for data collection at 12 months post-loading and CBCT.
- For socket-preserved sites with type-III/IV placement:
Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement.
Visit 2: Extraction, CBCT post extraction and provision of ARP. Visit 3: Suture removal after 1-2 weeks. Visit 4: Visit 5: Provision of type III/IV placement after 12-24weeks. Visit 5: Suture removal after 1-2 weeks. Visit 6: Provision of second stage surgery after 12-14 weeks. Visit 7: Impressions for temporary restoration after 2 weeks. Visit 8: Provision of temporary restoration after 2-4 weeks. Visit 9: Impressions for final restoration after 3-6 months. Visit 10: Provision of final implant restoration. Visit 11: Final visit for data collection at 12 months post-loading and CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a prospective, parallel-group, randomized study. This study will include three groups: i. Immediate dental implant placement with autogenous connective tissue graft (type I). ii. Early dental implant placement (type II). iii. Delayed/late dental implant placement in socket-preserved sites (type III/IV).
| Arm | Type | Receives |
|---|---|---|
| Type I dental implant placement. | Experimental | Procedure: Type I Dental implant placement.Type I dental implant placement (immediately after extraction) |
| Type II dental implant placement. | Experimental | Procedure: Type II Dental implant placement.Type II dental implant placement (6-8 weeks after extraction) |
| Type III/IV placement. | Experimental | Procedure: Type III/IV dental implant placement.Type III/IV placement in socket preserved sites after 3-6 months. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥23 years old.
- Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for two thirds of the root not associated with acute periapical pathology.
- Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of >50% buccal bone loss, the participant will be withdrawn from the study.
- Patient in good general health as documented by self-assessment. v) Full mouth bleeding and plaque scores (FMBS <10% and FMPS <30%) recorded within the previous 8 weeks.
Key exclusion criteria (7 listed)
- Uncontrolled or untreated periodontal disease. ii) History of local (head and neck) radiation therapy. iii) Presence of oral lesions in the area of the extraction (such as ulceration, malignancy).
- Severe bruxing or clenching habits. v) Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible).
- Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. AIDS).
- History of alcohol or drug abuse. viii) Smokers. ix) Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
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 |
|---|---|---|
| Type I Dental implant placement.Placement of dental implant. | Procedure or surgery | Type I dental implant placement. |
| Type II Dental implant placement.Placement of dental implant. | Procedure or surgery | Type II dental implant placement. |
| Type III/IV dental implant placement.Placement of dental implant. | Procedure or surgery | Type III/IV placement. |
Primary outcome
Combined success rate criteria.
Time frame: 12 months after delivery of implant restoration.
This is the success criteria described by Ong et al. 2008, in combintation with predetermined scores for PES/WES as decribed in Garcia-Sanchez et al. 2021.
25 secondary outcomes
Pre-treatment outcome. Total Need for further bone augmentation.
Time frame: At implant placement.
Pre-treatment outcome. Alveolar ridge dimensions clinically.
Time frame: Immediately after dental extraction for type I, at month 2 for type II, at month 4 for type III/IV and at second stage surgery (10-12 weeks after implant placement) for all groups.
Pre-treatment outcome. Alveolar ridge dimensions radiographic:
Time frame: Immediately after dental extraction for type I, at month 2 for type II, at month 4 for type III/IV and at 12 months post-loading for all groups.
Pre-treatment outcome. Periodontal phenotype
Time frame: Before dental extraction.
Pre-treatment outcome. Keratinised attached gingivae before extraction.
Time frame: Before dental extraction.
Pre-treatment outcome. Thickness of buccal wall (radiographic) before extraction.
Time frame: Before dental extraction
Pre-treatment outcome. Soft tissue thickness buccally.
Time frame: Before dental extraction.
Pre-treatment outcome. Soft tissue recession.
Time frame: Before dental extraction
Pre-treatment outcome. Sounding of soft tissue vertical at proximal sites.
Time frame: Before dental extraction and at implant placement.
Implant-related outcome. Survival at 12 months post-loading.
Time frame: At 12-months post-loading.
Implant-related outcome. Feasibility of implant placement.
Time frame: At implant placement.
Implant-related outcome. Final torque placement.
Time frame: At implant placement.
Implant-related outcome. Need for further soft tissue augmentation (soft tissue contour deficiencies).
Time frame: At implant placement or second stage surgery (10-12 weeks after dental implant placement).
Implant-related outcomes. Total surgical hours.
Time frame: Overall surgical time in that specific arm group.
Implant-related outcome. Papillary Fill Index
Time frame: At 1 and 12 months post-loading.
Implant-related outcome. Proximal bone levels (radiographic)
Time frame: At 1 and 12 months post-loading.
Implant-related outcome. Probing pocket depth around implants.
Time frame: At 1 and 12 months post-loading.
Implant-related outcome. Intra - surgical complications.
Time frame: At dental implant placement
Implant-related outcome. Post-surgical complications.
Time frame: Period from implant placement to implant loading. Normally this period last between 10-12 weeks.
Implant-related outcome. Technical/ mechanical complications
Time frame: At 1 and 12 months post-loading.
Implant-related outcome. Biologic complications.
Time frame: At 1 and 12 months post-loading.
Implant-related outcome. Post-operative clinical measurements.
Time frame: Immediately after extraction and at 12 month post-loading
Implant-related outcome.Histomorphometry of new bone formation in type III/IV implant placement.
Time frame: At 3 months of healing at the dental implant group III/IV.
Patient-reported outcome. VAS pain score after surgery for each group.
Time frame: 2 weeks after implant placement surgery.
Patient-reported outcome. Patient satisfaction with treatment outcome.
Time frame: At 12 months post-loading.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Yes. Datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Guillermo Pardo Zamora (gparza@um.es). This data will become available once the study results are published. The data available will be all of the individual participant data collected during the trial, after deidentification. This data will be available 3 months after publication and ending 5 years following article publication. This data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The data will be shared to achieve the aims in the approved proposal. Proposals should be directed to Dr Guillermo Pardo Zamora (gparza@um.es). To gain access, data requestors will need to sign a data access agreement.
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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.
Guillermo Pardo Zamora, Dr. study director
Universidad de Murcia. Associate Professor.
Ruben Garcia-Sanchez, Dr. principal investigator
Universidad de Murcia. Associate Professor.
Questions about this trial
What is this clinical trial studying?
A study testing Type I Dental implant placement., Type II Dental implant placement. and Type III/IV dental implant placement. in people with Dental Implant, run by Hospital General Universitario Morales Meseguer.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruben Garcia-Sanchez, Dr. ((+44)7864929396, ruben.garciasanchez@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined success rate criteria. (time frame: 12 months after delivery of implant 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 14 Aug 2023.