Interimplant MucosaNCT03787355
Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments
A study testing Morse connection Implants in people with Interimplant Mucosa, run by Cairo University at 1 site in Egypt.
Trial summary
The complete fill of the inter-implant mucosa is much more challenging between two implants, than single implants, and is considered to be unpredictable (Tymstra et al., 2011). However, previous clinical studies have pointed to a relationship between the inter-implant mucosa fill and the horizontal distance between… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interimplant Mucosa
- What is being tested?
- Morse connection Implants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Feb 2019to 15 Jan 2026
- 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
- Systemically healthy patients.
- Good oral hygiene.
- Missing minimum of two neighboring maxillary teeth with sufficient bucco-palatal bone of ≥ 6mm.
- Interimplant distance planned to be 3-4 mm.
- Patient acceptance of more than one year of follow up.
Who cannot join
- Vertically deficient ridges. (≤10 mm)
- Smokers.
- Pregnant females.
- Thin biotype
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments: A Randomized Controlled Clinical Trial
The complete fill of the inter-implant mucosa is much more challenging between two implants, than single implants, and is considered to be unpredictable (Tymstra et al., 2011). However, previous clinical studies have pointed to a relationship between the inter-implant mucosa fill and the horizontal distance between two adjacent implants. In particular, a greater inter-implant bone loss and the absence of the inter-implant mucosa were noted when neighboring implants were not separated by more than 3 mm (Tarnow, Magner and Fletcher, 1992).
The implant-abutment connection may have an impact on the amount such inter-implant bone loss, with morse-taper (MT) abutments emerging from the central region of the implant allow additional thickness in the horizontal soft-tissue component. This might help reducing marginal bone remodeling during biological width formation. Moreover, the literature indicates that the peri-implant bone strain vary significantly with the type of implant-abutment connection. The conical interface of MT connections helps dissipating the forces to the fixture.
The aim of the study is to clinically investigate the fate of soft tissue and papilla following crown placement on neighboring morse cone implants versus non-platform switched implants denoting the fate of soft tissue and papilla.
Read the detailed description
- Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Oral and Dental Medicine - Cairo University, Egypt.
- Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Intervention:
Clinical examination:
- Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
- Evaluation of the periapical condition and crestal bone level using a periapical radiograph.
- Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal probe.
- Width of keratinized gingiva (measured by a periodontal probe from the gingival margin to the mucogingival junction). It is measured at three areas (mesial, midbuccal and distal).
SURGICAL PROTOCOL (T0):
- Patients meeting the inclusion criteria, CBCT analysis and extensive diagnosis is done to plan for treatment.
- After randomization patients are assigned to one of the two groups
- After profound anesthesia administration, a full thickness crestal flap is reflected, sequential osteotomy of the implant sites to the desired depth is performed with great care of interimplant distance maintenance to a 3-4mm.
- Implant insertion and confirmatory x-rays are performed.
- Gingival formers will be placed.
- Flap closure is performed with interrupted 4-0 polyproplene sutures.
Postoperative Care:
Postoperative medication -Administration of:
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) (Francesco Pieri et al, 2012).
- Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse) will be prescribed starting from the second day for 60 seconds two times a day for 14 days (Jun Yu et al, 2015). -Patient self-care instructions:
- Application of an ice bag to the treated area for the first 24 hours (Francesco Pieri et al, 2012).
- The patients were instructed to gently brush the operated area starting from the second day with a soft brush using roll technique.
Scheduled time of re-entry for patients:
3 months for prosthesis fabrication.
Clinical Examinations:
At the 3-month (T1), 6-month (T2) and 12-month (T3), the following clinical parameters will be recorded at the implant sites: Interimplant vertical papilla height, pink esthestic score (PES), probing depth (PD), peri-implant mucosal height (PMH), bleeding on probing at six sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual), and width of buccal keratinized mucosa (KM) at the midbuccal surface of each implant.
KM will be recorded as the linear distance from the mucosal margin to the mucogingival line.
Radiographic Examination Radiographic examination will be performed immediately after the surgical procedure (T0), and at T1 and T3. Standard periapical radiographs will be taken using a digital imaging software system.
- Conditions
- Interimplant Mucosa
- Being tested
- Morse connection Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morse connection ImplantsCombination product
2 neighboring morse connection Implants of Zinedent - Strauman
| Study group | Role | What they receive |
|---|---|---|
| Cone Morse Connection Implants | Experimental | 2 neighboring Morse connection Implants Receives: Combination Product: Morse connection Implants |
| platform matched implants | Active comparator | 2 neighboring platform matched implants. Receives: Combination Product: Morse connection Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical papilla height
Change will be measured using periodontal probe in millimeters,
Measured: 6,12 months from T0 (Implant insertion)
Secondary outcomes (6)
Pink esthetic score (PES)
Numerical Rating Score (Fürhauser et al, 2005)
Measured: 12 months from T0 (Implant insertion)
Crestal bone resorption
Using digital X-ray, bone resorption will be measured using a software in mm.
Measured: T0 at the time of implant insertion, T1 at 3 months after implant insertion and at T3 at 12 months after implant insertion.
Probing depth (PD)
six sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual)
Measured: 3, 6,12 months from T0 (Implant insertion)
Bleeding on probing (BOP)
Binary, Using periodontal probe.
Measured: at T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).
Width of buccal keratinized mucosa (KM)
Measured at the midbuccal surface of each implant using periodontal probe in mm.
Measured: 3, 6,12 months from T0 (Implant insertion)
Patient satisfaction (cleaning, food impaction)
Measured using Numerical Rating Scale (NRS) (Kiyak et al, 1984)
Measured: At T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start17 Feb 2019
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interimplant MucosaStudies 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
- Model description
- Intervention versus Control.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Zazou, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787355
- Sponsor's protocol ID
- PERIO7:4:85
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2018
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03787355
- Acronym / sponsor ID
- PERIO7:4:85
- Conditions
- Interimplant Mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Feb 2019 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 26 Dec 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.
The complete fill of the inter-implant mucosa is much more challenging between two implants, than single implants, and is considered to be unpredictable (Tymstra et al., 2011). However, previous clinical studies have pointed to a relationship between the inter-implant mucosa fill and the horizontal distance between two adjacent implants. In particular, a greater inter-implant bone loss and the absence of the inter-implant mucosa were noted when neighboring implants were not separated by more than 3 mm (Tarnow, Magner and Fletcher, 1992).
The implant-abutment connection may have an impact on the amount such inter-implant bone loss, with morse-taper (MT) abutments emerging from the central region of the implant allow additional thickness in the horizontal soft-tissue component. This might help reducing marginal bone remodeling during biological width formation. Moreover, the literature indicates that the peri-implant bone strain vary significantly with the type of implant-abutment connection. The conical interface of MT connections helps dissipating the forces to the fixture.
The aim of the study is to clinically investigate the fate of soft tissue and papilla following crown placement on neighboring morse cone implants versus non-platform switched implants denoting the fate of soft tissue and papilla.
Detailed description
- Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Oral and Dental Medicine - Cairo University, Egypt.
- Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University.
Intervention:
Clinical examination:
- Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
- Evaluation of the periapical condition and crestal bone level using a periapical radiograph.
- Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal probe.
- Width of keratinized gingiva (measured by a periodontal probe from the gingival margin to the mucogingival junction). It is measured at three areas (mesial, midbuccal and distal).
SURGICAL PROTOCOL (T0):
- Patients meeting the inclusion criteria, CBCT analysis and extensive diagnosis is done to plan for treatment.
- After randomization patients are assigned to one of the two groups
- After profound anesthesia administration, a full thickness crestal flap is reflected, sequential osteotomy of the implant sites to the desired depth is performed with great care of interimplant distance maintenance to a 3-4mm.
- Implant insertion and confirmatory x-rays are performed.
- Gingival formers will be placed.
- Flap closure is performed with interrupted 4-0 polyproplene sutures.
Postoperative Care:
Postoperative medication -Administration of:
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) (Francesco Pieri et al, 2012).
- Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse) will be prescribed starting from the second day for 60 seconds two times a day for 14 days (Jun Yu et al, 2015). -Patient self-care instructions:
- Application of an ice bag to the treated area for the first 24 hours (Francesco Pieri et al, 2012).
- The patients were instructed to gently brush the operated area starting from the second day with a soft brush using roll technique.
Scheduled time of re-entry for patients:
3 months for prosthesis fabrication.
Clinical Examinations:
At the 3-month (T1), 6-month (T2) and 12-month (T3), the following clinical parameters will be recorded at the implant sites: Interimplant vertical papilla height, pink esthestic score (PES), probing depth (PD), peri-implant mucosal height (PMH), bleeding on probing at six sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual), and width of buccal keratinized mucosa (KM) at the midbuccal surface of each implant.
KM will be recorded as the linear distance from the mucosal margin to the mucogingival line.
Radiographic Examination Radiographic examination will be performed immediately after the surgical procedure (T0), and at T1 and T3. Standard periapical radiographs will be taken using a digital imaging software system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention versus Control.
| Arm | Type | Receives |
|---|---|---|
| Cone Morse Connection Implants | Experimental | Combination Product: Morse connection Implants2 neighboring Morse connection Implants |
| platform matched implants | Active comparator | Combination Product: Morse connection Implants2 neighboring platform matched implants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy patients.
- Good oral hygiene.
- Missing minimum of two neighboring maxillary teeth with sufficient bucco-palatal bone of ≥ 6mm.
- Interimplant distance planned to be 3-4 mm.
- Patient acceptance of more than one year of follow up.
Key exclusion criteria (4 listed)
- Vertically deficient ridges. (≤10 mm)
- Smokers.
- Pregnant females.
- Thin biotype
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 |
|---|---|---|
| Morse connection Implants2 neighboring morse connection Implants of Zinedent - Strauman | Combination product | Cone Morse Connection Implants, platform matched implants |
Primary outcome
Vertical papilla height
Time frame: 6,12 months from T0 (Implant insertion)
Change will be measured using periodontal probe in millimeters,
6 secondary outcomes
Pink esthetic score (PES)
Time frame: 12 months from T0 (Implant insertion)
Crestal bone resorption
Time frame: T0 at the time of implant insertion, T1 at 3 months after implant insertion and at T3 at 12 months after implant insertion.
Probing depth (PD)
Time frame: 3, 6,12 months from T0 (Implant insertion)
Bleeding on probing (BOP)
Time frame: at T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).
Width of buccal keratinized mucosa (KM)
Time frame: 3, 6,12 months from T0 (Implant insertion)
Patient satisfaction (cleaning, food impaction)
Time frame: At T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morse connection Implants in people with Interimplant Mucosa, 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 5 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: finished, as of the sponsor's last update on 16 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vertical papilla height (time frame: 6,12 months from T0 (Implant insertion)). 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 16 Jan 2026.