An interventional study of ball attachment and cm loc attachment in Complete Edentulism, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-12.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around implant when compared to conventional ball attachment
Ball attachments are very commonly used because they are solitary, simple, easier to use and less technique sensitive if compared to bar attachments. However, ball attachment require a prosthetic space of 12 mm and could show tremendous wear if implants were mal-aligned. CM LOC attachment is newly introduced into market with very good expectations regarding its properties and effect on the periimplant soft tissue. CM LOC attachment, which combes titanium patrix and resin matrix made from polyetherketoneketone (PEKK), is a very promising material regarding the wear and the prosthesis retention it provides, even with mal-aligned implants. However, the clinical performance of this attachment was not tested yet. Therefore, in this randomized controlled trial it was decided to compare between CM LOC and the commonly used ball attachment regarding the soft tissue health and marginal bone loss.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the conventional ball attachment
Device: ball attachment
completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the cm loc attachment
Device: cm loc attachment
it is attachment part that connects the overdenture to the implant
Also known as: metallic ball attachment
It is a new attachment made of peek material
Soft tissue reaction :Presence of mucositis
it is a binary outcome that is measured by either its presence or absence
Time frame: [from baseline up to 1 year]
Modified gingival Index
0 = absence of inflammation 1. = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary 2. = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary 3. = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary 4. = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. Gingival units as well as the calculation of the index follow the same criteria described in GI
Time frame: from baseline up to 1 year. score measurement from 0-4 where 0 is no inflammation and 4 is severe inflammation
Modified Plaque Index
Modified Plaque Index (mPI) is a dental plaque scale done by Mombelli etal.\[13\] as follows: 0 = No plaque 1. = Separate flecks of plaque at the cervical margin 2. = Plaque can be seen by naked eye 3. = Abundance of soft matter. The lower the number the less plaque is present on the tooth
Time frame: from baseline upto 1 year. score measurement from 0-3 where 0 denotes no plaque present and 3 denotes abundant plaque
Modified Bleeding Index
Periodontal probe will be passed all around implant cervical margin and bleeding will be scored as follows: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding.
Time frame: from baseline upto 1 year. score from 0-3 where 0 denotes no bleeding and 3 denotes profound bleeding
marginal bone loss
Standardized periapical long cone paralleling technique will be necessary so radiographic template customized for each patient with a holder. Then two reference points will be marked on the implant platform surface and will be joined with a line representing the height zero. then two vertical lines mesial and distal will be drawn to the first bone contact point.
Time frame: from baseline up to 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University