Atrophy of Edentulous Mandibular Alveolar RidgeNCT03540316
Treatment Outcome of Short Implant Assisted Mandibular Overdenture
A study testing Two short implants and 2 minutes LLLT, Two short implants and 4 minutes LLLT and Four short implants and 2 minutes LLLT in people with Atrophy of Edentulous Mandibular Alveolar Ridge, run by Sara Zayed at 1 site in Egypt.
Trial summary
This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short… Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophy of Edentulous Mandibular Alveolar Ridge
- What is being tested?
- Two short implants and 2 minutes LLLT, Two short implants and 4 minutes LLLT and Four short implants and 2 minutes LLLT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to Jan 2024
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients.
- Patients with mandibular resorbed edentulous ridge.
- Medically fit patients with no systemic conditions.
- Class I ridge relation.
- Adequate zone of keratinized mucosa.
Who cannot join
- Metabolic bone disease or unstable systemic condition.
- Heavy smokers.
- A history of radiotherapy in the head and neck region.
- Physical or mental disability.
- Temporomandibular and neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy
This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.
Read the detailed description
The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.
- Being tested
- Two short implants and 2 minutes LLLT, Two short implants and 4 minutes LLLT, Four short implants and 2 minutes LLLT, Four short implants and 4 minutes LLLT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two short implants and 2 minutes LLLTCombination product
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.
Two short implants and 4 minutes LLLTCombination product
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.
Four short implants and 2 minutes LLLTCombination product
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.
Four short implants and 4 minutes LLLTCombination product
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Two short implants and 2 minutes LLLT | Active comparator | Patients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes . Receives: Combination Product: Two short implants and 2 minutes LLLT |
| Two short implants and 4 minutes LLLT | Active comparator | Patients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes . Receives: Combination Product: Two short implants and 4 minutes LLLT |
| Four short implants and 2 minutes LLLT | Active comparator | Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes . Receives: Combination Product: Four short implants and 2 minutes LLLT |
| Four short implants and 4 minutes LLLT | Active comparator | Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes . Receives: Combination Product: Four short implants and 4 minutes LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in implant stability (Implant Stability Quotient).
Implant stability can be defined as the absence of clinical mobility. It will be assessed at the time of implant placement (baseline) ,then six months and twelve months later, by the resonance frequency analysis using Osstel devise which measure implant oscillation frequency on the bone;Implant Stability Quotient (ISQ) .
Measured: Baseline, 6 months &12 months.
Secondary outcomes (3)
Peri-implant marginal bone changes.
Radiographic assessment of bone level changes around each implant will be performed to detect peri-implant crestal bone changes using standardised digital periapical x-ray. It will be assessed at the time of implant placement, six months and twelve months later.
Measured: Baseline, 6 months &12 months.
Assessment of changes in peri-implant probing depth .
Peri-implant probing depth is the distance between the gingival margin and the most apically probeable portion, in millimetres. It will be measured at four sites of each implant (mesially, labially, distally, lingually) by using a graduated periodontal probe which will be held parallel to the long axis of the implant and introduced to the peri-implant sulcus till there is slight resistance. The mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion then, six months and twelve months after implant placement.
Measured: Baseline, 6 months &12 months.
Assessment of changes in modified gingival index
To qualify the degree of peri-implant inflammation, the modified gingival index will be used. It will be measured at four sites around each implant (mesially, labially, distally, lingually) and the mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion, then six months and twelve months after implant placement.
Measured: Baseline, 6 months &12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 May 2018
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrophy of Edentulous Mandibular Alveolar RidgeStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Zayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Zayed, Alexandria University
- Investigators
- Sara Zayed, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540316
- Sponsor's protocol ID
- 01032018
- Status last verified
- Jul 2021
- First submitted
- 2 May 2018
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.
PubMed 19696851Maniewicz S, Buser R, Duvernay E, Vazquez L, Loup A, Perneger TV, Schimmel M, Muller F. Short Dental Implants Retaining Two-Implant Mandibular Overdentures in Very Old, Dependent Patients: Radiologic and Clinical Observation Up to 5 Years. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):415-422. doi: 10.11607/jomi.5361.
PubMed 28291859Mandic B, Lazic Z, Markovic A, Mandic B, Mandic M, Djinic A, Milicic B. Influence of postoperative low-level laser therapy on the osseointegration of self-tapping implants in the posterior maxilla: a 6-week split-mouth clinical study. Vojnosanit Pregl. 2015 Mar;72(3):233-40. doi: 10.2298/vsp131202075m.
PubMed 25958474Malo P, de Araujo Nobre M, Rangert B. Short implants placed one-stage in maxillae and mandibles: a retrospective clinical study with 1 to 9 years of follow-up. Clin Implant Dent Relat Res. 2007 Mar;9(1):15-21. doi: 10.1111/j.1708-8208.2006.00027.x.
PubMed 17362493Zayed SM, Noureldin MG. Rehabilitation of Atrophic Mandible with Ultrashort Implants Combined with Photobiomodulation Therapy: A Split-Mouth Design Study. Saudi J Med Med Sci. 2022 Sep-Dec;10(3):198-206. doi: 10.4103/sjmms.sjmms_635_21. Epub 2022 Aug 22.
PubMed 36247059
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy
- ClinicalTrials.gov ID
- NCT03540316
- Acronym / sponsor ID
- 01032018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sara ZayedUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 30 May 2018 (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.
This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.
Detailed description
The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Two short implants and 2 minutes LLLT | Active comparator | Combination Product: Two short implants and 2 minutes LLLTPatients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes . |
| Two short implants and 4 minutes LLLT | Active comparator | Combination Product: Two short implants and 4 minutes LLLTPatients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes . |
| Four short implants and 2 minutes LLLT | Active comparator | Combination Product: Four short implants and 2 minutes LLLTPatients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes . |
| Four short implants and 4 minutes LLLT | Active comparator | Combination Product: Four short implants and 4 minutes LLLTPatients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes . |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous patients.
- Patients with mandibular resorbed edentulous ridge.
- Medically fit patients with no systemic conditions.
- Class I ridge relation.
- Adequate zone of keratinized mucosa.
Key exclusion criteria (5 listed)
- Metabolic bone disease or unstable systemic condition.
- Heavy smokers.
- A history of radiotherapy in the head and neck region.
- Physical or mental disability.
- Temporomandibular and neuromuscular disorders.
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 |
|---|---|---|
| Two short implants and 2 minutes LLLTPatients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes. | Combination product | Two short implants and 2 minutes LLLT |
| Two short implants and 4 minutes LLLTPatients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes. | Combination product | Two short implants and 4 minutes LLLT |
| Four short implants and 2 minutes LLLTPatients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes. | Combination product | Four short implants and 2 minutes LLLT |
| Four short implants and 4 minutes LLLTPatients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes. | Combination product | Four short implants and 4 minutes LLLT |
Primary outcome
Assessment of changes in implant stability (Implant Stability Quotient).
Time frame: Baseline, 6 months &12 months.
Implant stability can be defined as the absence of clinical mobility. It will be assessed at the time of implant placement (baseline) ,then six months and twelve months later, by the resonance frequency analysis using Osstel devise which measure implant oscillation frequency on the bone;Implant Stability Quotient (ISQ) .
3 secondary outcomes
Peri-implant marginal bone changes.
Time frame: Baseline, 6 months &12 months.
Assessment of changes in peri-implant probing depth .
Time frame: Baseline, 6 months &12 months.
Assessment of changes in modified gingival index
Time frame: Baseline, 6 months &12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Background: PubMed 19696851Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.
- Background: PubMed 28291859Maniewicz S, Buser R, Duvernay E, Vazquez L, Loup A, Perneger TV, Schimmel M, Muller F. Short Dental Implants Retaining Two-Implant Mandibular Overdentures in Very Old, Dependent Patients: Radiologic and Clinical Observation Up to 5 Years. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):415-422. doi: 10.11607/jomi.5361.
- Background: PubMed 25958474Mandic B, Lazic Z, Markovic A, Mandic B, Mandic M, Djinic A, Milicic B. Influence of postoperative low-level laser therapy on the osseointegration of self-tapping implants in the posterior maxilla: a 6-week split-mouth clinical study. Vojnosanit Pregl. 2015 Mar;72(3):233-40. doi: 10.2298/vsp131202075m.
- Background: PubMed 17362493Malo P, de Araujo Nobre M, Rangert B. Short implants placed one-stage in maxillae and mandibles: a retrospective clinical study with 1 to 9 years of follow-up. Clin Implant Dent Relat Res. 2007 Mar;9(1):15-21. doi: 10.1111/j.1708-8208.2006.00027.x.
- Derived from this study: PubMed 36247059Zayed SM, Noureldin MG. Rehabilitation of Atrophic Mandible with Ultrashort Implants Combined with Photobiomodulation Therapy: A Split-Mouth Design Study. Saudi J Med Med Sci. 2022 Sep-Dec;10(3):198-206. doi: 10.4103/sjmms.sjmms_635_21. Epub 2022 Aug 22.
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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.
Sara Zayed study director
Alexandria 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 Two short implants and 2 minutes LLLT, Two short implants and 4 minutes LLLT and Four short implants and 2 minutes LLLT in people with Atrophy of Edentulous Mandibular Alveolar Ridge, run by Sara Zayed 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 5 inclusion and 5 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 27 Jul 2021. 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?
Assessment of changes in implant stability (Implant Stability Quotient). (time frame: Baseline, 6 months &12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540316, which also lists 5 linked publications.
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 27 Jul 2021.