| CTRI Number |
CTRI/2023/06/054239 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
20/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of less invasive grafting of gums around dental implants in the back side region of lower jaw - A randomized controlled trial |
|
Scientific Title of Study
|
Efficacy of a minimally invasive buccal roll technique for peri-implant soft tissue augmentation in the mandibular posterior region - A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shiphalika Sinha |
| Designation |
Post-graduate |
| Affiliation |
SDM College of Dental Sciences and Hospital, Dharwad |
| Address |
Dept. of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital,
Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7411609398 |
| Fax |
|
| Email |
shiphalika117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiphalika Sinha |
| Designation |
Post-graduate |
| Affiliation |
SDM College of Dental Sciences and Hospital, Dharwad |
| Address |
Dept. of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital,
Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7411609398 |
| Fax |
|
| Email |
shiphalika117@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mihir Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Dental Sciences and Hospital, Dharwad |
| Address |
Dept. of Periodontics and Oral Implantology, SDM College of Dental Sciences and Hospital,
Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7411609398 |
| Fax |
|
| Email |
mihir.mrk271@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Shiphalika Sinha, Department of Periodontics. 7SDM College of Dental Sciences & Hospital, Sattur, Dharwad - 580009 |
| SDM College of Dental Sciences and Hospital, Dharwad, Karnataka, India, PIN - 580009 |
|
|
Primary Sponsor
|
| Name |
Dr Shiphalika Sinha |
| Address |
Dept. of Periodontics and Oral Implantology, SDM college of Dental Sciences and Hospital,
Sattur, Dharwad, KARNATAKA |
| 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 Shiphalika Sinha |
S.D.M.COLLEGE OF DENTAL SCIENCES AND HOSPITAL |
Room number 3, Department of
Oral Implantology, SDM
College of Dental
Sciences, Dharwad, Karnataka
Dharwad
KARNATAKA |
7411609398
shiphalika117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Dental Sciences and Hospital - Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K06||Other disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional second stage surgery |
In the conventional technique, a mid crestal incision will be
given at the implant site followed by elevation of a
full thickness flap on both buccal and lingual
aspect, following which the cover screw will be
unscrewed and a suitable gingival former will be
placed along with sutures to approximate the flap.
The procedure takes 30 mins to execute and would be performed at baseline, the follow-up would be for 6 months.
|
| Intervention |
Minimally invasive buccal roll
technique |
The procedure will be performed under local
anesthesia in both the groups, in the test group a
split thickness flap will be outlined according to
the dimensions of the underlying coverscrew,
further a full thickness flap will be raised from the
lingual aspect of the outline and tunnelled on the
buccal aspect.
The flap will then be tucked in to the pouch on the
buccal aspect followed by placement of a suitable
gingival former.
The procedure takes 30 mins to execute and would be performed at baseline, the follow-up would be for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
No systemic diseases or pregnancy.
No probing depths ≥ 5mm.
Full-mouth plaque score (FMPS) and full mouth bleeding score (FMBS) ≤ 15%
(measured at four sites per tooth).
Need of soft tissue augmentation in
mandibular posterior sites to maintain the
natural ridge contour and increase the
thickness of tissue buccolingually.
No previous soft tissue augmentation
procedure at experimental site. |
|
| ExclusionCriteria |
| Details |
Disease affecting connective tissue
metabolism
Pregnant or lactating women
Untreated periodontal disease.
Dental implants previously uncovered or
applied with a single -stage procedure.
No residual keratinized tissue (KT) at
experimental area.
Radiographs revealing presence of bone on
the cover screw.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess & compare the following outcomes
after a minimally invasive buccal roll/conventional
second stage surgery –
Bucco-lingual ridge width (RW)
Width of keratinized mucosa (KTW)
Thickness of keratinized mucosa (MT)
|
At baseline 3 months 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess & compare the following outcomes
after a minimally invasive buccal roll/conventional
second stage surgery –
1. Alveolar crest height
2. Probing depth
3. Bleeding on probing
4. Pink esthetic score |
At 3 months 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
30/06/2023 |
| 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="0"
Months="6"
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
|
Introduction Problem statement - The posterior mandibular sites are found to have
thinner peri-implant tissues when compared to the
other sites which can make them more prone to
recession and collapse of the ridge contour around
the implant, affecting the esthetics and peri-implant mucosal health. Research question - Is a minimally invasive buccal roll technique
better in comparison to conventional second stage
technique in maintaining the natural ridge contour of peri-implant soft tissues in the mandibular
posterior region? Research hypotheses - Minimally invasive buccal roll technique is
effective in maintaining the ridge contour and
esthetics of peri-implant soft tissue in the
mandibular posterior region compared to control
group.
Objectives of the study Primary objective
To assess and compare the following outcomes
after a minimally invasive buccal roll/conventional
second stage surgery –
Bucco-lingual ridge width (RW)
Width of keratinized mucosa (KTW)
Thickness of keratinized mucosa (MT) Secondary objectives
To assess and compare the following outcomes
after a minimally invasive buccal roll/conventional
second stage surgery –
1. Alveolar crest height
2. Probing depth
3. Bleeding on probing
4. Pink esthetic score
Study procedure The patients fulfilling the inclusion criteria will be
randomized into two groups of test (Modified
buccal roll) and control (Conventional second
stage) by computer generated number.
The procedure will be performed under local
anesthesia in both the groups, in the test group a
split thickness flap will be outlined according to
the dimensions of the underlying coverscrew,
further a full thickness flap will be raised from the
lingual aspect of the outline and tunnelled on the
buccal aspect.
The flap will then be tucked in to the pouch on the
buccal aspect followed by placement of a suitable
gingival former.
In the control group, a mid crestal incision will be
given at the implant site followed by elevation of a
full thickness flap on both buccal and lingual
aspect, following which the cover screw will be
unscrewed and a suitable gingival former will be
placed along with sutures to approximate the flap.
|