| CTRI Number |
CTRI/2025/06/089553 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two different types of implant abutment connections in dental implants and their role in preserving gingival health and marginal bone levels in patients with different interocclusal spaces. |
|
Scientific Title of Study
|
Evaluation of gingival health and marginal bone levels in platform switching and platform matching implant abutment connections with different interocclusal space- A Randomised controlled trial |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sherly R |
| Designation |
MDS Junior Resident |
| Affiliation |
Government Dental College, Kozhikode |
| Address |
Room No 50, Department of Prosthodontics, Government Dental College, Kozhikode.
Kozhikode
KERALA
673008
India |
| Phone |
8608825546 |
| Fax |
|
| Email |
sherlyrajkumarm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar A V |
| Designation |
Head of Department of Prosthodontics |
| Affiliation |
Government Dental College, Kozhikode. |
| Address |
Room No 50, Department of Prosthodontics , Government Dental College, Kozhikode.
Kozhikode
KERALA
673008
India |
| Phone |
9447169055 |
| Fax |
|
| Email |
pramodav@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sherly R |
| Designation |
MDS Junior Resident |
| Affiliation |
Government Dental College, Kozhikode. |
| Address |
Room No 50, Department of Prosthodontics, Government Dental College, Kozhikode.
Kozhikode
KERALA
673008
India |
| Phone |
8608825546 |
| Fax |
|
| Email |
sherlyrajkumarm@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sherly R |
| Address |
Junior Resident, Department of Prosthodontics Government Dental College, Kozhikode -673008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sherly R |
Government Dental College, Kozhikode |
Room No 50, Department of Prosthodontics, Government Dental College, Government Medical College Campus, Kozhikode - 673008
Kozhikode
KERALA |
8608825546
sherlyrajkumarm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT DENTAL COLLEGE, KOZHIKODE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Platform matching implant with flared abutment interface |
In patients with interocclusal space greater than 12 mm for a duration of nine months from the time of implant placement. |
| Comparator Agent |
Platform matching implant with flared abutment interface |
In patients with interocclusal space of 8 - 12 mm for a duration of nine months from the time of implant placement. |
| Intervention |
Platform Matching implant with Flared abutment interface |
In patients with interocclusal space of less than 8 mm for a duration of nine months from the time of implant placement. |
| Comparator Agent |
Platform Matching implant with straight abutment interface |
In patients with interocclusal space greater than 12 mm for a duration of nine months from the time of implant placement. |
| Comparator Agent |
Platform Matching implant with straight abutment interface |
In patients with interocclusal space of 8 - 12 mm for a duration of nine months from the time of implant placement. |
| Comparator Agent |
Platform Matching implant with straight abutment interface |
In patients with interocclusal space of less than 8 mm for a duration of nine months from the time of implant placement. |
| Comparator Agent |
Platform switching Implant with conical connection |
In patients with interocclusal space greater than 12 mm for a duration of nine months from the time of implant placement. |
| Comparator Agent |
Platform switching Implant with conical connection |
In patients with interocclusal space of 8 - 12 mm for a duration of nine months from the time of implant placement. |
| Comparator Agent |
Platform switching Implant with conical connection |
In patients with interocclusal space of less than 8 mm for a duration of nine months from the time of implant placement. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with missing single or two molar teeth in the maxillary and mandibular region.
2. Systemically healthy participants without any history of periodontal disease and
smoking.
3. Patients having stable occlusion.
4. Edentulous region should be well rounded with adequate keratinised mucosa.
5. Patients with good oral hygiene.
6. Edentulous site with adequate mesiodistal space for replacing molar teeth.
7. Edentulous site with non tilted adjacent teeth. |
|
| ExclusionCriteria |
| Details |
1. Patients developing systemic disease like diabetes mellitus etc, during the course of the
study.
2. Participants who are pregnant or becoming pregnant during the course of the study.
3. Patients failing to obtain osseointegration after implant placement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of Gingival Health:
1. Bleeding on Probing
2. Periodontal Pocket depth
3. Plaque index. |
One week after final prosthesis delivery, and follow up at three and Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of radiographic marginal bone levels |
After final prosthesis delivery, & follow up at three & six months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The success of implants relies heavily on the design of the implant-abutment interface, which affects load distribution, bacterial seal, soft tissue health, and emergence profile. Two main implant-abutment design includes platform switching and platform matching. Also flared abutments mimic natural tooth contours better than straight ones. Interocclusal height also influences gingival health and restoration outcomes.
While previous studies have explored the effects of platform switching and platform matching on bone preservation and soft tissue health, the specific impact of these configurations on the emergence profile, especially in the molar region when combined with varying interocclusal heights, remains inadequately studied. Therefore, the study is a randomised controlled trial to evaluate the gingival health and marginal bone levels between 3 groups of implant abutment platforms – platform matching with straight abutment interface, platform matching with flared abutment interface and platform switching with conical connection with various interocclusal heights in a total of 72 patients with missing teeth in the molar region.
The primary outcome variable is to evaluate the gingival parameters (bleeding on probing, peri implant probing depth and plaque index in the groups. The secondary outcome variable is to evaluate the radiographic marginal bone levels in implants in the following groups. The outcomes will be measured after final prosthesis delivery, 3 months and 6 months after insertion |